Family Centered CareNCT05717075
Effects of Parents Included in Medical Round of Neonatal Intensive Care Unit
A study testing Parents Round in people with Family Centered Care and Decision Making, run by Nagano Children's Hospital at 1 site in Japan.
Trial summary
The goal of this cross-over randomized controlled study is to evaluate the effects of medical rounds with parents. The main questions it aims to answer are: How feasible the protocol of this study is to include parents in the medical round? Does the Family Round promote the quality of family centered care in the NICU… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Family Centered Care, Decision Making
- What is being tested?
- Parents Round
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteJapan
- Study dates
- 5 Mar 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants in the NICU and their parents/partner
- Infants who are expected to stay in the NICU for more than one month in the future at consent
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Parents Included in Decision-making During Medical Round in Neonatal Intensive Care Unit: Cross-over Randomized Controlled Trial
The goal of this cross-over randomized controlled study is to evaluate the effects of medical rounds with parents. The main questions it aims to answer are:
- How feasible the protocol of this study is to include parents in the medical round?
- Does the Family Round promote the quality of family centered care in the NICU perceived by parents and healthcare staff?
- Does the Family Round promote parent-infant bonding?
- Does the Family Round reduce parents' anxiety?
- Does the Family Round increase parents' satisfaction?
- Does the Family Round improve staff's communication skills to integrate parents in the discussion of medical rounds?
Read more
Participants will participate in the Family Round for two weeks, which is organized by healthcare staff following a protocol aiming to integrate parents into the discussion.
They will be compared to the two-week period without the Family Round.
Read the detailed description
[Intervention] The intervention included in this study is called "Parents Round," which aims to integrate parents into the discussion of medical rounds. Parents Round is organized by healthcare staff following the protocol. The protocol details are described below.
Essential requirements
- Limited number of participants: infant, parents, other important family members if present, up to 2 doctors, and up to 4 healthcare staff including doctors
- At the bedside of the infant
- All participants, excluding the infant, sit on the chair
- Privacy consideration: ask the other parents in the same room to go out or wear headphone
- Ask parents about their infant's condition and their opinion before the healthcare staff speaks
- Mention the respiration, feeding, skin-to-skin contact, and involvement in care-taking and try to make a decision collaboratively with parents about the short- or long-term plan in each item
Recommended requirements
- Quiet environment: turn off or reduce the volume of the monitor alarm
- Effective communication to promote parents' participation and involvement: parents speaking first, empathetic attitude, not interrupting while parents speak, and not frequently using the technical term, for example.
- Encourage psychologists to participate
- Nurses complement parents' role and may lead some parts of the discussion: e.g. discharge preparation
[Sample size] To detect the mean difference of 0.5 in the FCC-Q average scores (standard deviation, 0.77), with power 0.8 and alfa 0.05 in the cross-over trial, at least 40 families are necessary. We estimate the possibility of dropout as 10% and, finally, the target sample size is decided to be 46 families (or 92 parents) in total.
[Randomization] After families consent to participate, they are randomly assigned to Group A (intervention first) or Group B (no intervention first). The randomization sequence will be created using Excel 2019 (Microsoft, Redmond, WA, USA) and will be stratified based on the gestational age at birth (preterm births [born before 37 weeks of gestation] or full-term birth [born 37 weeks of gestation or later]) with a 1:1 allocation using random block sizes of 2 and 4.
The sequence allocation was conducted by a researcher in the research group who will not be involved in family enrollment. The allocated number was concealed from the researcher enrolling and assessing participating families in sequentially numbered, opaque, sealed, and stapled envelopes. This sealing will be conducted by another research member who will not be involved in the enrollment process. Black thick paper will be used inside the envelope to prevent the allocated number from being visible from the outside. The neonatologists in the study group, except for one person working outside the unit, will be responsible for the family enrollment. One of the envelopes will be opened soon after the family's consent by the person who is responsible for the enrollment according to the number written outside the envelope. To prevent subversion of the allocation sequence, the infant's name, identification number, and date of birth will be written on the envelope before opening it and on the paper on which the allocated number is printed soon after opening it. Any blinding is not possible in this study design after allocating the families.
[Statistics] The differences in each continuous outcome measures (FCC-Q, Short-STAI, and Satisfaction questionnaire) between the intervention and the control will be analyzed using the linear mixed model: including intervention/control, Period I/II, an interaction effect of the intervention and the period, and the infant's days of life at each intervention/control phase as covariates and parent as a random effect.
In addition, the proportion of parents with possible clinical state or trait anxiety will be also compared using the cutoff score of > 9.5 in state and > 13.5 in trait anxiety 8. The generalized mixed model will be used to compare the two groups: including intervention/control, Period I/II, an interaction effect of the intervention and the period, and the infant's days of life at the assessment as covariates and parent as a random effect.
The differences in the outcome measures for healthcare staff will be analyzed using the Wilcoxon rank sum test. Additionally, the adjusted outcomes will be estimated using the linear mixed model. The following variables will be included in the model: the outcome measure, occupation, and years of experience as fixed effects, and each healthcare staff as a mixed effect.
All analyses will be conducted for both parents together and individually. Separate analyses will be conducted including and excluding those who never participate in the Family Round during the study period. The differences in each question in FCC-Q or the Satisfaction questionnaire will be also compared. The state and trait anxiety measured by Short-STAI will be analyzed separately. The proportion of each rating in the Bliss Baby Charter audit tool will be compared between the groups using the Wilcoxon rank sum test. R and RStudio will be used to analyze the data. The analyses performed are two-tailed, and P <.05 is considered statistically significant.
[Data management] Running numbers will be assigned to every family after the consent. All data will be handled pseudonymously after converting the data into electronic data. Paper documents including parents' answers will be stored in a safe archive of the unit. Electronic data will be stored in a password-protected computer. All paper and electronic data will be destroyed 10 years after the final publication.
The principal investigator will be responsible for managing access to the data. The other research members will also have the right to access the digital data. The data is co-owned by the members of the research team. We do not have the plan to make the data open in the future. However, it can be shared with another personnel or research team for another scientific purpose with the permission of the principal investigator.
- Conditions
- Family Centered Care, Decision Making
- Being tested
- Parents Round
- Keywords
- Medical round, Doctor's round
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents RoundBehavioural
The intervention carried out in this study is called Family Round. The Family Round is an additional medical round, aiming to involve parents in the discussion. The basic attitude of the healthcare staff is to make decisions collaboratively with parents or other family members based on the parents' observations of their infant and parents' opinions. As our daily medical round is carried out in the morning between 8 and 10 a.m. and we offer no accommodation for parents in the NICU, the Family Round will be carried out separately in the afternoon. One neonatologist who is in charge of the infant or taking care of the infant on that day will be a facilitator and proceed with the Parent Round according to the protocol. Other healthcare staff are also encouraged to participate, although the number of participants is limited.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Parents Round, then no special round) | Other | Parents of enrolled patient receive the intervention for two weeks after the consent to the study (Period I). For two weeks after the intervention in Period I, the parents do not receive the intervention (Period II). Receives: Behavioral: Parents Round |
| Group B (no special round, then Parents Round) | Other | Parents of enrolled patient receive no intervention for two weeks after the consent to the study (Period I). For two weeks after Period I, the parents receive the intervention (Period II). Receives: Behavioral: Parents Round |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of family centered care assessed by parents
The family centered care provided by the NICU is assessed by parents using FCC-Q, which was modified from DigFCC SMS questions. It consists of 9 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) participation in medical round/medical care decision making, 8) received information, and 9) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
Measured: 2 weeks
Quality of family centered care assessed by parents
The family centered care provided by the NICU is assessed by parents using FCC-Q, which was modified from DigFCC SMS questions. It consists of 9 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) participation in medical round/medical care decision making, 8) received information, and 9) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
Measured: 4 weeks
Quality of family centered care assessed by healthcare staff
The family centered care provided by the NICU is assessed by parents or healthcare staff using FCC-Q, which was modified from DigFCC SMS questions. It consists of 8 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) received information, and 8) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
Measured: before the enrollment of the first patient
Quality of family centered care assessed by healthcare staff
The family centered care provided by the NICU is assessed by parents or healthcare staff using FCC-Q, which was modified from DigFCC SMS questions. It consists of 8 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) received information, and 8) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
Measured: 1 month after the end of the intervention of the last patient
Secondary outcomes (11)
Bonding feeling of parens toward their infant
The bonding feelings of parents toward their infant is assessed using the Japanese version of MIBS-J. It has ten self-report items, each of which is scored on a four-point scale (0-3). The total score varies from 0 to 30, and higher scores indicate problematic bonding feelings.
Measured: 2 weeks
Bonding feeling of parens toward their infant
The bonding feelings of parents toward their infant is assessed using the Japanese version of MIBS-J. It has ten self-report items, each of which is scored on a four-point scale (0-3). The total score varies from 0 to 30, and higher scores indicate problematic bonding feelings.
Measured: 4 weeks
Parents' anxiety
Parents' anxiety is assessed using the short version of the State and Trait Anxiety Inventory (Short-STAI). It was developed based on the original STAI which has 40 questions.9 The STAI assesses two different anxiety types at the same time. State anxiety is an emotional response that can change over time according to the situation. Trait anxiety indicates a personal emotional characteristic that a person has. There are 5 questions for each state and trait anxiety and each is scored on a four-point scale (1-4). The total score in each type of anxiety varies from a minimum of 5 to a maximum of 20, and higher scores indicate having more depressive symptoms.
Measured: 2 weeks
Parents' anxiety
Parents' anxiety is assessed using the short version of the State and Trait Anxiety Inventory (Short-STAI). It was developed based on the original STAI which has 40 questions.9 The STAI assesses two different anxiety types at the same time. State anxiety is an emotional response that can change over time according to the situation. Trait anxiety indicates a personal emotional characteristic that a person has. There are 5 questions for each state and trait anxiety and each is scored on a four-point scale (1-4). The total score in each type of anxiety varies from a minimum of 5 to a maximum of 20, and higher scores indicate having more depressive symptoms.
Measured: 4 weeks
Parents' satisfaction
Parents' satisfaction is assessed using a satisfaction questionnaire, which was made for this study purpose. It consists of 5 questions and each question is evaluated using the visual analogue scale (VAS). The VAS has a continuous bar from 0 to 100% and parents choose the point that best fits their thoughts. Here are the questions included.
- Was the information about your baby sufficient and accurately delivered to you?
- Did the healthcare staff listen to you well and respect your ideas?
- When deciding how you would be involved in your baby's care, were your thoughts fully reflected?
- When deciding your baby's future plan, were your thoughts taken into account and did you join the discussion together with the healthcare staff?
- What is your overall level of satisfaction?
Measured: 2 weeks
Parents' satisfaction
Parents' satisfaction is assessed using a satisfaction questionnaire, which was made for this study purpose. It consists of 5 questions and each question is evaluated using the visual analogue scale (VAS). The VAS has a continuous bar from 0 to 100% and parents choose the point that best fits their thoughts. Here are the questions included.
- Was the information about your baby sufficient and accurately delivered to you?
- Did the healthcare staff listen to you well and respect your ideas?
- When deciding how you would be involved in your baby's care, were your thoughts fully reflected?
- When deciding your baby's future plan, were your thoughts taken into account and did you join the discussion together with the healthcare staff?
- What is your overall level of satisfaction?
Measured: 4 weeks
Quality of medical round with parents assessed by parents
Another questionnaire will be answered by parents at the end of the study. It includes questions to explore the facilitating and inhibiting factors for parents' participation in the medical round.
Measured: 4 weeks
Collaboration competence questionnaire of healthcare staff
Healthcare staff's ability to work collaboratively with parents will be assessed using the collaboration competence questionnaire. The questionnaire is specifically created to assess competencies that are relevant for the Close Collaboration with Parents intervention. The questionnaire includes 21 questions that are evaluated with scale from 1 to 10 (1=not competent at all, 10=extremely competent). If the question does not ably the daily work role of the professional option "Doesn't belong to my role" can be chosen.
Measured: before the enrollment of the first patient
Collaboration competence questionnaire of healthcare staff
Healthcare staff's ability to work collaboratively with parents will be assessed using the collaboration competence questionnaire. The questionnaire is specifically created to assess competencies that are relevant for the Close Collaboration with Parents intervention. The questionnaire includes 21 questions that are evaluated with scale from 1 to 10 (1=not competent at all, 10=extremely competent). If the question does not ably the daily work role of the professional option "Doesn't belong to my role" can be chosen.
Measured: 1 month after the end of the intervention of the last patient
Quality of family centered care assessed by healthcare staff using the Bliss Baby Charter audit tool
The Bliss Baby Charter audit tool is a self-assessment tool to evaluate the quality of family centered care in neonatal intensive care units. The tool has 7 core principles and a total of 141 statements. All principles contain different aspects of family centered care: active care by parent and staff, parent and family support, communication, developmental care, empowered decision making, facilities, guidelines and policies, staff skills and training, information provision, and service improvement and parent involvement. Each statement is rated as green (fully delivering against all aspects of the criteria), amber (Delivering some or most of the aspects required to meet the criteria but not all), or red (Delivering none or very few of the aspects required to fulfil that criteria). The rating can be done by both healthcare staff and parents.
Measured: before the enrollment of the first patient
Quality of family centered care assessed by healthcare staff using the Bliss Baby Charter audit tool
The Bliss Baby Charter audit tool is a self-assessment tool to evaluate the quality of family centered care in neonatal intensive care units. The tool has 7 core principles and a total of 141 statements. All principles contain different aspects of family centered care: active care by parent and staff, parent and family support, communication, developmental care, empowered decision making, facilities, guidelines and policies, staff skills and training, information provision, and service improvement and parent involvement. Each statement is rated as green (fully delivering against all aspects of the criteria), amber (Delivering some or most of the aspects required to meet the criteria but not all), or red (Delivering none or very few of the aspects required to fulfil that criteria). The rating can be done by both healthcare staff and parents.
Measured: 1 month after the end of the intervention of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start5 Mar 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Centered CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagano Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryo Itoshima, Nagano Children's Hospital
- Investigators
- +81-263-73-6700 Itoshima, MD, Principal investigator, Nagano Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717075
- Sponsor's protocol ID
- Parents round RCT
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parents Included in Decision-making During Medical Round in Neonatal Intensive Care Unit: Cross-over Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05717075
- Acronym / sponsor ID
- Parents round RCT
- Conditions
- Family Centered Care, Decision Making
- Keywords
- Medical round, Doctor's round
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Nagano Children's HospitalUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this cross-over randomized controlled study is to evaluate the effects of medical rounds with parents. The main questions it aims to answer are:
- How feasible the protocol of this study is to include parents in the medical round?
- Does the Family Round promote the quality of family centered care in the NICU perceived by parents and healthcare staff?
- Does the Family Round promote parent-infant bonding?
- Does the Family Round reduce parents' anxiety?
- Does the Family Round increase parents' satisfaction?
- Does the Family Round improve staff's communication skills to integrate parents in the discussion of medical rounds?
Participants will participate in the Family Round for two weeks, which is organized by healthcare staff following a protocol aiming to integrate parents into the discussion.
They will be compared to the two-week period without the Family Round.
Detailed description
[Intervention] The intervention included in this study is called "Parents Round," which aims to integrate parents into the discussion of medical rounds. Parents Round is organized by healthcare staff following the protocol. The protocol details are described below.
Essential requirements
- Limited number of participants: infant, parents, other important family members if present, up to 2 doctors, and up to 4 healthcare staff including doctors
- At the bedside of the infant
- All participants, excluding the infant, sit on the chair
- Privacy consideration: ask the other parents in the same room to go out or wear headphone
- Ask parents about their infant's condition and their opinion before the healthcare staff speaks
- Mention the respiration, feeding, skin-to-skin contact, and involvement in care-taking and try to make a decision collaboratively with parents about the short- or long-term plan in each item
Recommended requirements
- Quiet environment: turn off or reduce the volume of the monitor alarm
- Effective communication to promote parents' participation and involvement: parents speaking first, empathetic attitude, not interrupting while parents speak, and not frequently using the technical term, for example.
- Encourage psychologists to participate
- Nurses complement parents' role and may lead some parts of the discussion: e.g. discharge preparation
[Sample size] To detect the mean difference of 0.5 in the FCC-Q average scores (standard deviation, 0.77), with power 0.8 and alfa 0.05 in the cross-over trial, at least 40 families are necessary. We estimate the possibility of dropout as 10% and, finally, the target sample size is decided to be 46 families (or 92 parents) in total.
[Randomization] After families consent to participate, they are randomly assigned to Group A (intervention first) or Group B (no intervention first). The randomization sequence will be created using Excel 2019 (Microsoft, Redmond, WA, USA) and will be stratified based on the gestational age at birth (preterm births [born before 37 weeks of gestation] or full-term birth [born 37 weeks of gestation or later]) with a 1:1 allocation using random block sizes of 2 and 4.
The sequence allocation was conducted by a researcher in the research group who will not be involved in family enrollment. The allocated number was concealed from the researcher enrolling and assessing participating families in sequentially numbered, opaque, sealed, and stapled envelopes. This sealing will be conducted by another research member who will not be involved in the enrollment process. Black thick paper will be used inside the envelope to prevent the allocated number from being visible from the outside. The neonatologists in the study group, except for one person working outside the unit, will be responsible for the family enrollment. One of the envelopes will be opened soon after the family's consent by the person who is responsible for the enrollment according to the number written outside the envelope. To prevent subversion of the allocation sequence, the infant's name, identification number, and date of birth will be written on the envelope before opening it and on the paper on which the allocated number is printed soon after opening it. Any blinding is not possible in this study design after allocating the families.
[Statistics] The differences in each continuous outcome measures (FCC-Q, Short-STAI, and Satisfaction questionnaire) between the intervention and the control will be analyzed using the linear mixed model: including intervention/control, Period I/II, an interaction effect of the intervention and the period, and the infant's days of life at each intervention/control phase as covariates and parent as a random effect.
In addition, the proportion of parents with possible clinical state or trait anxiety will be also compared using the cutoff score of > 9.5 in state and > 13.5 in trait anxiety 8. The generalized mixed model will be used to compare the two groups: including intervention/control, Period I/II, an interaction effect of the intervention and the period, and the infant's days of life at the assessment as covariates and parent as a random effect.
The differences in the outcome measures for healthcare staff will be analyzed using the Wilcoxon rank sum test. Additionally, the adjusted outcomes will be estimated using the linear mixed model. The following variables will be included in the model: the outcome measure, occupation, and years of experience as fixed effects, and each healthcare staff as a mixed effect.
All analyses will be conducted for both parents together and individually. Separate analyses will be conducted including and excluding those who never participate in the Family Round during the study period. The differences in each question in FCC-Q or the Satisfaction questionnaire will be also compared. The state and trait anxiety measured by Short-STAI will be analyzed separately. The proportion of each rating in the Bliss Baby Charter audit tool will be compared between the groups using the Wilcoxon rank sum test. R and RStudio will be used to analyze the data. The analyses performed are two-tailed, and P <.05 is considered statistically significant.
[Data management] Running numbers will be assigned to every family after the consent. All data will be handled pseudonymously after converting the data into electronic data. Paper documents including parents' answers will be stored in a safe archive of the unit. Electronic data will be stored in a password-protected computer. All paper and electronic data will be destroyed 10 years after the final publication.
The principal investigator will be responsible for managing access to the data. The other research members will also have the right to access the digital data. The data is co-owned by the members of the research team. We do not have the plan to make the data open in the future. However, it can be shared with another personnel or research team for another scientific purpose with the permission of the principal investigator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Parents Round, then no special round) | Other | Behavioral: Parents RoundParents of enrolled patient receive the intervention for two weeks after the consent to the study (Period I). For two weeks after the intervention in Period I, the parents do not receive the intervention (Period II). |
| Group B (no special round, then Parents Round) | Other | Behavioral: Parents RoundParents of enrolled patient receive no intervention for two weeks after the consent to the study (Period I). For two weeks after Period I, the parents receive the intervention (Period II). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Infants in the NICU and their parents/partner
- Infants who are expected to stay in the NICU for more than one month in the future at consent
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parents RoundThe intervention carried out in this study is called Family Round. The Family Round is an additional medical round, aiming to involve parents in the discussion. The basic attitude of the healthcare staff is to make decisions collaboratively with parents or other family members based on the parents' observations of their infant and parents' opinions. As our daily medical round is carried out in the morning between 8 and 10 a.m. and we offer no accommodation for parents in the NICU, the Family Round will be carried out separately in the afternoon. One neonatologist who is in charge of the infant or taking care of the infant on that day will be a facilitator and proceed with the Parent Round according to the protocol. Other healthcare staff are also encouraged to participate, although the number of participants is limited. | Behavioural | Group A (Parents Round, then no special round), Group B (no special round, then Parents Round) |
Primary outcome
Quality of family centered care assessed by parents
Time frame: 2 weeks
The family centered care provided by the NICU is assessed by parents using FCC-Q, which was modified from DigFCC SMS questions. It consists of 9 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) participation in medical round/medical care decision making, 8) received information, and 9) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
Quality of family centered care assessed by parents
Time frame: 4 weeks
The family centered care provided by the NICU is assessed by parents using FCC-Q, which was modified from DigFCC SMS questions. It consists of 9 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) participation in medical round/medical care decision making, 8) received information, and 9) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
Quality of family centered care assessed by healthcare staff
Time frame: before the enrollment of the first patient
The family centered care provided by the NICU is assessed by parents or healthcare staff using FCC-Q, which was modified from DigFCC SMS questions. It consists of 8 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) received information, and 8) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
Quality of family centered care assessed by healthcare staff
Time frame: 1 month after the end of the intervention of the last patient
The family centered care provided by the NICU is assessed by parents or healthcare staff using FCC-Q, which was modified from DigFCC SMS questions. It consists of 8 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) received information, and 8) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.
11 secondary outcomes
Bonding feeling of parens toward their infant
Time frame: 2 weeks
Bonding feeling of parens toward their infant
Time frame: 4 weeks
Parents' anxiety
Time frame: 2 weeks
Parents' anxiety
Time frame: 4 weeks
Parents' satisfaction
Time frame: 2 weeks
Parents' satisfaction
Time frame: 4 weeks
Quality of medical round with parents assessed by parents
Time frame: 4 weeks
Collaboration competence questionnaire of healthcare staff
Time frame: before the enrollment of the first patient
Collaboration competence questionnaire of healthcare staff
Time frame: 1 month after the end of the intervention of the last patient
Quality of family centered care assessed by healthcare staff using the Bliss Baby Charter audit tool
Time frame: before the enrollment of the first patient
Quality of family centered care assessed by healthcare staff using the Bliss Baby Charter audit tool
Time frame: 1 month after the end of the intervention of the last patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
+81-263-73-6700 Itoshima, MD principal investigator
Nagano Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents Round in people with Family Centered Care and Decision Making, run by Nagano Children's Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of family centered care assessed by parents (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.