Neonatal Intensive Care UnitNCT04478162
The Effect of Family Integrated Care on Preparing Parents With Premature Infants Hospitalized in the Neonatal Intensive Care Unit for Discharge
A study testing Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model. in people with Neonatal Intensive Care Unit and Parents, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Physiological and structural features of premature infants differ from mature newborns. Families worry about touching their very sensitive and fragile babies, which are quite different from their expectations, and they seriously concern about how they will take care of their babies who are cared for by the specialist… Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Intensive Care Unit, Parents
- What is being tested?
- Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model.
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Feb 2020to 15 Aug 2021
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Birth of the infant at the 28th-34th weeks of gestation,
- First parenting experience of the mother and the father,
- Parents' willingness to participate in the study and being open to communication,
- Mother having breast milk,
- Participation of parents in the discharge training program.
Who cannot join
- Undergoing a surgical intervention,
- Death of the baby
- Transfer of the baby to another hospital,
- Failure of the parent to complete all phases of the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya Education and Training Hospital
Sakarya, Adapazarı, 54050
About this study
Official title: Investigation of the Effect of Family Integrated Care Method on Preparedness for Discharge
Physiological and structural features of premature infants differ from mature newborns. Families worry about touching their very sensitive and fragile babies, which are quite different from their expectations, and they seriously concern about how they will take care of their babies who are cared for by the specialist staff at the hospital when they are discharged to home. Different approaches and models are applied in the Neonatal Intensive Care Units (NICU) to prepare families, especially mothers, for the discharge process and to overcome these fears of the parents. However, most of the time, investigators observe in both researches and units that these approaches are not efficient. In this study, which investigators started with the questions as "What can investigators do better in this issue?" and "How can investigators help families more in this process?", investigator have seen that Family Integrated Care (FICare) model is applied in some clinics abroad and successful results have been obtained. However, investigators did not come across a study that applied this model and examined the effect of it on parents on being ready for discharge. Since this study will be a first in terms of both this aspect and the application of this model in our country, in this unique study, investigators aim to draw attention to this approach in our country, also contribute to keeping the premature babies healthy.
Research Hypotheses:
Read more
H0 There is no difference between the readiness for discharge of mothers and fathers included in the FICare model compared to the control group.
H1 The hypothesis of this study is that the mothers included in the FICare model have higher levels of discharge readiness than the control group.
H2 The hypothesis of this study is that the fathers included in the FICare model have higher levels of discharge readiness than the control group.
Read the detailed description
Background: The Family Integrated Care (FICare) model is a modern approach that supports the participation of parents (excluding ventilation, monitor adjustments, vascular fluid and drug administration) developed in collaboration between parents and healthcare professionals, which is carried out gradually in the NICU (1). Parents are informed about the general development of the baby, brain and sensory development, motor and behavior development, care of the premature. In addition, parents are informed about what they can do about general body cleaning and care, especially in touch, attachment, skin-to-skin contact, breastfeeding and increased breast milk and diaper change (2).FICare; It is a care model with a 25% increase in the weight gain of premature babies, a 80% increase in breastfeeding rate, a 25% decrease in parental stress, a significant decrease in critical incident reports such as hospital infection and sudden infant death (3). The care that these babies receive in their first hours, days, weeks and months is vital to determine their future health and long-term outcomes. Evidence suggests that if parents are supported and encouraged to take care of their babies while in hospital, this will have better outcomes for both the baby and their family. FICare support not only reduces the length of hospital stay of parents, but also reduces the rate of re-hospitalization, and strengthens the bond between parents and babies. It helps parents feel safer when taking care of their babies, both in the hospital and at home (4).
A standard care model for discharge preparation is not applied to parents who have a premature baby in their NICU. Institutions make the decision to discharge with the opinions of the doctor and nurse working in the unit. With the FICare model, it is thought that parents will be prepared for discharge, bonding between parents and babies, fulfilling their parental roles, supporting babies' breastfeeding, reducing hospital stay, enhancing parental-employee communication, and increasing the quality of care services..
Premature infants who were hospitalized for at least seven days between February 6, 2020, and August 15, 2021, in the NICU of a training and research hospital formed the population of the study. In the study, the total number of parents was determined as 68 when the margin of error was 5%, the power level was 81.17%, and the effect size value was 0.70. At the end of the study, a post hoc power analysis was conducted to determine the adequacy of the sample size. As a result of the power analysis, for the details of the difference between the groups in terms of the scale score of fathers with premature babies in the neonatal intensive care unit, type 1 error: 0.05, n: 68 people, effect size = 1.990, and the power level according to the structure was determined as 1.000. To determine the difference in terms of the scale score of mothers with premature babies in the neonatal intensive care unit, type 1 error: 0.05, n: 68 people, effect size = 2.586 and power level according to temperature was determined as 1.000. These values show that the sample size is sufficient.
- Conditions
- Neonatal Intensive Care Unit, Parents
- Being tested
- Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model.
- Keywords
- premature, Family Integrated Care, discharge, readiness, parents
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model.Other
At least 1 week of FICare training for parents At least 4 hours of training on FICare for health professionals Trainings will be held between 13:30 and 15:30 in a training room with heat, light and seating arrangement (for parents who are not able to participate in the training during the week, trainings will be held at the appropriate time interval on the weekend .) Premature baby dummy on oral care, eye care, nose care, ear care, skin care, bath, attired in clothes,/removal, safe sleeping baby, safe transport, kangaroo care (physical contact), non-invasive drug application will be shown and the parents also will be asked to implement,
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All phases of the FICare model have been implemented. Parents in the intervention group were included in a one-week training program within the scope of the Family Integrated Care model. A maximum of four couples attended the training in each session. A training program was also organized at weekend for those who could not attend it during the week. Training subjects consisted of the importance of breast milk, breastfeeding positions, hygienic care practices (eyes, nose, mouth, ears, skin, diaper change), bathing, nail clipping, kangaroo care, drug administration, first and emergency support, safe sleep, doctor check-up times, and vaccine follow-ups. Care practices were first shown on the model infant, and parents were asked to practice on the model. When the clinical stabilization of their infants was achieved, parents were asked to attend at least three caregiving sessions and stay in the hospital for an average of six to eight hours. Receives: Other: Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model. |
| Control Groups | No intervention | Individuals received usual care provided by nurses from the time the premature infant was admitted to the NICU until discharge. The usual care process is carried on between the nurse and the mother. Mothers are allowed to perform limited care practices (bottom cleaning, breastfeeding) that the nurse considers appropriate. Mothers of babies who are planned to be discharged start staying in the hospital approximately 2 days before. Fathers are not included in the care and process. They are not allowed to stay in the hospital. Fathers are only informed and not included in the care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Integrated Care model and evaluation of routine care practicesevaluation) will increase the readiness of parents.
With the questionnaire to be used separately for mothers (Preparedness for Discharge Scale of the Mother with a Premature Baby in the Neonatal Intensive Care Unit) and fathers (Preparedness for Discharge Scale of the Father with a Premature Baby in the Neonatal Intensive Care Unit) with premature babies, their readiness for discharge will be measured. A minimum score of 22, a maximum of 154 points are obtained from the form applied to mothers, a minimum of 20 and a maximum of 140 points from the form applied to fathers. High scores indicate that parents are ready for discharge.
Measured: up to nine months
Secondary outcomes (1)
Premature infants weight (kg)
Body weight will be measured every day from the day the baby is admitted to NICU until the day she is discharged.Body weight will be measured every day from the day the baby is admitted to NICU until the day she is discharged.
Measurements obtained by the percentile curve are evaluated.
Measured: up to nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start6 Feb 2020
- Primary completion15 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, öznur tiryaki, Sakarya University
- Investigators
- Nursan ÇINAR, Proffesor, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478162
- Sponsor's protocol ID
- 16214662/050.01.04/14
- Status last verified
- Dec 2023
- First submitted
- 27 Jun 2020
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: * Planning of the study, literature review, development of data collection tools, preparation of training slides and videos, provision of materials to be used in the study (2 months) * Application of Family Integrated Care model, Collection of Data (10 months) * Statistical analysis and evaluation of results (1 months) * Writing the research report (2 months)
Publications
Tiryaki O, Cinar N, Caner I. The effect of family integrated care on preparing parents with premature infants hospitalized in the neonatal intensive care unit for discharge. J Perinatol. 2024 Jul;44(7):1014-1021. doi: 10.1038/s41372-024-01931-5. Epub 2024 Mar 18.
PubMed 38499753
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Family Integrated Care Method on Preparedness for Discharge
- ClinicalTrials.gov ID
- NCT04478162
- Acronym / sponsor ID
- 16214662/050.01.04/14
- Conditions
- Neonatal Intensive Care Unit, Parents
- Keywords
- premature, Family Integrated Care, discharge, readiness, parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 20 Jul 2020 (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.
Physiological and structural features of premature infants differ from mature newborns. Families worry about touching their very sensitive and fragile babies, which are quite different from their expectations, and they seriously concern about how they will take care of their babies who are cared for by the specialist staff at the hospital when they are discharged to home. Different approaches and models are applied in the Neonatal Intensive Care Units (NICU) to prepare families, especially mothers, for the discharge process and to overcome these fears of the parents. However, most of the time, investigators observe in both researches and units that these approaches are not efficient. In this study, which investigators started with the questions as "What can investigators do better in this issue?" and "How can investigators help families more in this process?", investigator have seen that Family Integrated Care (FICare) model is applied in some clinics abroad and successful results have been obtained. However, investigators did not come across a study that applied this model and examined the effect of it on parents on being ready for discharge. Since this study will be a first in terms of both this aspect and the application of this model in our country, in this unique study, investigators aim to draw attention to this approach in our country, also contribute to keeping the premature babies healthy.
Research Hypotheses:
H0 There is no difference between the readiness for discharge of mothers and fathers included in the FICare model compared to the control group.
H1 The hypothesis of this study is that the mothers included in the FICare model have higher levels of discharge readiness than the control group.
H2 The hypothesis of this study is that the fathers included in the FICare model have higher levels of discharge readiness than the control group.
Detailed description
Background: The Family Integrated Care (FICare) model is a modern approach that supports the participation of parents (excluding ventilation, monitor adjustments, vascular fluid and drug administration) developed in collaboration between parents and healthcare professionals, which is carried out gradually in the NICU (1). Parents are informed about the general development of the baby, brain and sensory development, motor and behavior development, care of the premature. In addition, parents are informed about what they can do about general body cleaning and care, especially in touch, attachment, skin-to-skin contact, breastfeeding and increased breast milk and diaper change (2).FICare; It is a care model with a 25% increase in the weight gain of premature babies, a 80% increase in breastfeeding rate, a 25% decrease in parental stress, a significant decrease in critical incident reports such as hospital infection and sudden infant death (3). The care that these babies receive in their first hours, days, weeks and months is vital to determine their future health and long-term outcomes. Evidence suggests that if parents are supported and encouraged to take care of their babies while in hospital, this will have better outcomes for both the baby and their family. FICare support not only reduces the length of hospital stay of parents, but also reduces the rate of re-hospitalization, and strengthens the bond between parents and babies. It helps parents feel safer when taking care of their babies, both in the hospital and at home (4).
A standard care model for discharge preparation is not applied to parents who have a premature baby in their NICU. Institutions make the decision to discharge with the opinions of the doctor and nurse working in the unit. With the FICare model, it is thought that parents will be prepared for discharge, bonding between parents and babies, fulfilling their parental roles, supporting babies' breastfeeding, reducing hospital stay, enhancing parental-employee communication, and increasing the quality of care services..
Premature infants who were hospitalized for at least seven days between February 6, 2020, and August 15, 2021, in the NICU of a training and research hospital formed the population of the study. In the study, the total number of parents was determined as 68 when the margin of error was 5%, the power level was 81.17%, and the effect size value was 0.70. At the end of the study, a post hoc power analysis was conducted to determine the adequacy of the sample size. As a result of the power analysis, for the details of the difference between the groups in terms of the scale score of fathers with premature babies in the neonatal intensive care unit, type 1 error: 0.05, n: 68 people, effect size = 1.990, and the power level according to the structure was determined as 1.000. To determine the difference in terms of the scale score of mothers with premature babies in the neonatal intensive care unit, type 1 error: 0.05, n: 68 people, effect size = 2.586 and power level according to temperature was determined as 1.000. These values show that the sample size is sufficient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model.All phases of the FICare model have been implemented. Parents in the intervention group were included in a one-week training program within the scope of the Family Integrated Care model. A maximum of four couples attended the training in each session. A training program was also organized at weekend for those who could not attend it during the week. Training subjects consisted of the importance of breast milk, breastfeeding positions, hygienic care practices (eyes, nose, mouth, ears, skin, diaper change), bathing, nail clipping, kangaroo care, drug administration, first and emergency support, safe sleep, doctor check-up times, and vaccine follow-ups. Care practices were first shown on the model infant, and parents were asked to practice on the model. When the clinical stabilization of their infants was achieved, parents were asked to attend at least three caregiving sessions and stay in the hospital for an average of six to eight hours. |
| Control Groups | No intervention | –Individuals received usual care provided by nurses from the time the premature infant was admitted to the NICU until discharge. The usual care process is carried on between the nurse and the mother. Mothers are allowed to perform limited care practices (bottom cleaning, breastfeeding) that the nurse considers appropriate. Mothers of babies who are planned to be discharged start staying in the hospital approximately 2 days before. Fathers are not included in the care and process. They are not allowed to stay in the hospital. Fathers are only informed and not included in the care. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Birth of the infant at the 28th-34th weeks of gestation,
- First parenting experience of the mother and the father,
- Parents' willingness to participate in the study and being open to communication,
- Mother having breast milk,
- Participation of parents in the discharge training program.
Key exclusion criteria (4 listed)
- Undergoing a surgical intervention,
- Death of the baby
- Transfer of the baby to another hospital,
- Failure of the parent to complete all phases of the study.
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 |
|---|---|---|
| Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model.At least 1 week of FICare training for parents At least 4 hours of training on FICare for health professionals Trainings will be held between 13:30 and 15:30 in a training room with heat, light and seating arrangement (for parents who are not able to participate in the training during the week, trainings will be held at the appropriate time interval on the weekend .) Premature baby dummy on oral care, eye care, nose care, ear care, skin care, bath, attired in clothes,/removal, safe sleeping baby, safe transport, kangaroo care (physical contact), non-invasive drug application will be shown and the parents also will be asked to implement, | Other | Experimental |
Primary outcome
Family Integrated Care model and evaluation of routine care practicesevaluation) will increase the readiness of parents.
Time frame: up to nine months
With the questionnaire to be used separately for mothers (Preparedness for Discharge Scale of the Mother with a Premature Baby in the Neonatal Intensive Care Unit) and fathers (Preparedness for Discharge Scale of the Father with a Premature Baby in the Neonatal Intensive Care Unit) with premature babies, their readiness for discharge will be measured. A minimum score of 22, a maximum of 154 points are obtained from the form applied to mothers, a minimum of 20 and a maximum of 140 points from the form applied to fathers. High scores indicate that parents are ready for discharge.
1 secondary outcome
Premature infants weight (kg)
Time frame: up to nine months
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 20 Dec 2023.
- Derived from this study: PubMed 38499753Tiryaki O, Cinar N, Caner I. The effect of family integrated care on preparing parents with premature infants hospitalized in the neonatal intensive care unit for discharge. J Perinatol. 2024 Jul;44(7):1014-1021. doi: 10.1038/s41372-024-01931-5. Epub 2024 Mar 18.
- httppLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. * Planning of the study, literature review, development of data collection tools, preparation of training slides and videos, provision of materials to be used in the study (2 months) * Application of Family Integrated Care model, Collection of Data (10 months) * Statistical analysis and evaluation of results (1 months) * Writing the research report (2 months)
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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.
Nursan ÇINAR, Proffesor principal investigator
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model. in people with Neonatal Intensive Care Unit and Parents, run by Sakarya University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 20 Dec 2023. 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 Turkey (Türkiye). 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?
Family Integrated Care model and evaluation of routine care practicesevaluation) will increase the readiness of parents. (time frame: up to nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04478162, which also lists 1 linked publication.
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 20 Dec 2023.