Very Low Birth Weight InfantNCT05483231
The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants
A study testing Family integrated care intervention group and Routine nursing care group in people with Very Low Birth Weight Infant, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study will explore the effect of Family integrated care (FICare) on the level of melatonin and other clinical outcomes in very low birth weight infants (VLBWIs) by integrating families into the neonatal intensive care unit (NICU) care team and participating in the daily care of VLBWIs, as well as the influence of… Read more about this study
- Who is it for?
- Ages 0 to 24 hours
- Conditions the study is for
- Very Low Birth Weight Infant
- What is being tested?
- Family integrated care intervention group and Routine nursing care group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Apr 2024
- 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 0 to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight < 1500g;
- Gestational age < 32w;
- Admit within 24 hours of birth;
- The parents are conscious and able to cooperate, have certain learning and reading comprehension skills, and are capable of caring for their babies. They are committed to receiving training and caring for their babies for not less than 6 hours a day for at least 21 days;
- Voluntarily participate in this study and sign informed consent.
Who cannot join
- Newborns who require palliative care or surgical intervention;
- OI (oxygenation index) <300 ;
- Newborns with severe congenital malformations;
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Xiaojing Hu, PhD, +8618017590869, humama2015@126.com
Yi Zhang, Master, +8618071608186, 20211170025@fudan.edu.cn
About this study
Official title: The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants in Neonatal Intensive Care Unit: A Multicenter Randomized Controlled Trial
This study will explore the effect of Family integrated care (FICare) on the level of melatonin and other clinical outcomes in very low birth weight infants (VLBWIs) by integrating families into the neonatal intensive care unit (NICU) care team and participating in the daily care of VLBWIs, as well as the influence of FIcare on parents' outcomes.
Read the detailed description
This study is a multicenter randomized controlled trial which mainly explores the effect of Family integrated care (FICare) on melatonin levels in very low birth weight infants (VLBWIs) in neonatal intensive care unit (NICU). The intervention group will use a FICare intervention program, mainly for families who have been fully trained by the NICU professional team and need to stay in the NICU to accompany and care for the VLBWIs for not less than 6 hours a day for at least 3 weeks. All non-medical care measures and developmental supportive care will be provided by parents as much as possible. The control group received routine nursing interventions in which all non-medical interventions are led by NICU staff and without parental involvement. The level of melatonin, clinical and parental outcomes in VLBWIs are compared between the intervention group and the control group to evaluate the effect of FICare intervention program.
- Conditions
- Very Low Birth Weight Infant
- Being tested
- Family integrated care intervention group, Routine nursing care group
- Keywords
- Family integrated care, Melatonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family integrated care intervention groupBehavioural
If the very low birth weight infants' vital signs are stable at 32 weeks of corrected gestational age, parents who have been fully trained will provide all non-medical care measures and developmental care for the VLBWIs in the NICU for not less than 6 hours per day for at least 3 weeks, and other medical practice and care measures will be the same as the routine group.
Routine nursing care groupBehavioural
Routine practice and in-hospital education will be given to the very low birth weight infants and parents. All care measures will be led by the nursing staff, without the participation of parents.
| Study group | Role | What they receive |
|---|---|---|
| Family integrated care intervention group | Experimental | Provide Family integrated care for very low birth weight infants in the NICU. Receives: Behavioral: Family integrated care intervention group |
| Routine nursing care group | Other | Perform routine nursing care for very low birth weight infants in the NICU. Receives: Behavioral: Routine nursing care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on the level of Melatonin in very low birth weight infants
At 32 weeks of corrected gestational age (baseline) and day 21 after the implementation of FICare intervention, melatonin will be quantitatively measured by high performance liquid chromatography-mass spectrometry (HPLC-MS) with saliva samples collected by a specially-assigned person.
Measured: From baseline to day 21 after the implementation of Family integrated care intervention
Secondary outcomes (6)
Breast feeding rate
Data will be acquired at the day 21 after the implementation of FICare intervention by a specially-assigned person. Breastfeeding rate = number of VLBWI fed from mother's milk/total number of VLBWI enrolled in each group *100%.
Measured: At the day 21 after the implementation of Family integrated care intervention
Changes in maternal milk volume
At 32 weeks of corrected gestational age (baseline) and day 21 after the implementation of FICare intervention, maternal milk volume will be collected from lactation diary records issued before the intervention.
Measured: From baseline to day 21 after the implementation of Family integrated care intervention
Rate of weight gain
Weight is measured by a parent or nurse. Rate of weight gain = ( Weight measured at day 21 after the intervention - weight measured at 32 weeks of corrected gestational age)/total number of intervention days.
Measured: From baseline to day 21 after the implementation of Family integrated care intervention
Incidence of complications related to preterm birth
Complications related to preterm birth include neonatal sepsis, bronchopulmonary dysplasia (BPD), intraventicular hemorrhage (IVH), periventricular leukinomalacia (PVL), and retinopathy of prematurity (ROP). These complications are diagnosed by a neonatologist. If any of these conditions occurred during the intervention, complications related to preterm birth would be considered. Data will be obtained from the case system or data collection form.
Measured: Through study completion, about an average of 21 days
Length of hospitalization
Length of hospitalization refers to the total number of days from 32 weeks of corrected gestational age (baseline) to the day of discharge. Data will be obtained from the case system.
Measured: Through study completion, about an average of 21 days
Growth rate of head circumference
Head circumference is measured by a parent or nurse. Growth rate of head circumference = ( head circumference measured at day 21 after the intervention - head circumference measured at 32 weeks of corrected gestational age)/total number of intervention days.
Measured: From baseline to day 21 after the implementation of Family integrated care intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Dec 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight InfantStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojing Hu, PhD, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483231
- Sponsor's protocol ID
- 2021-453
- Status last verified
- Aug 2023
- First submitted
- 28 Jun 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants in Neonatal Intensive Care Unit: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05483231
- Acronym / sponsor ID
- 2021-453
- Conditions
- Very Low Birth Weight Infant
- Keywords
- Family integrated care, Melatonin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 2 Aug 2022 (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.
This study will explore the effect of Family integrated care (FICare) on the level of melatonin and other clinical outcomes in very low birth weight infants (VLBWIs) by integrating families into the neonatal intensive care unit (NICU) care team and participating in the daily care of VLBWIs, as well as the influence of FIcare on parents' outcomes.
Detailed description
This study is a multicenter randomized controlled trial which mainly explores the effect of Family integrated care (FICare) on melatonin levels in very low birth weight infants (VLBWIs) in neonatal intensive care unit (NICU). The intervention group will use a FICare intervention program, mainly for families who have been fully trained by the NICU professional team and need to stay in the NICU to accompany and care for the VLBWIs for not less than 6 hours a day for at least 3 weeks. All non-medical care measures and developmental supportive care will be provided by parents as much as possible. The control group received routine nursing interventions in which all non-medical interventions are led by NICU staff and without parental involvement. The level of melatonin, clinical and parental outcomes in VLBWIs are compared between the intervention group and the control group to evaluate the effect of FICare intervention program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family integrated care intervention group | Experimental | Behavioral: Family integrated care intervention groupProvide Family integrated care for very low birth weight infants in the NICU. |
| Routine nursing care group | Other | Behavioral: Routine nursing care groupPerform routine nursing care for very low birth weight infants in the NICU. |
Who may qualify
- Ages
- 0 to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Birth weight < 1500g;
- Gestational age < 32w;
- Admit within 24 hours of birth;
- The parents are conscious and able to cooperate, have certain learning and reading comprehension skills, and are capable of caring for their babies. They are committed to receiving training and caring for their babies for not less than 6 hours a day for at least 21 days;
- Voluntarily participate in this study and sign informed consent.
Key exclusion criteria (3 listed)
- Newborns who require palliative care or surgical intervention;
- OI (oxygenation index) <300 ;
- Newborns with severe congenital malformations;
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 |
|---|---|---|
| Family integrated care intervention groupIf the very low birth weight infants' vital signs are stable at 32 weeks of corrected gestational age, parents who have been fully trained will provide all non-medical care measures and developmental care for the VLBWIs in the NICU for not less than 6 hours per day for at least 3 weeks, and other medical practice and care measures will be the same as the routine group. | Behavioural | Family integrated care intervention group |
| Routine nursing care groupRoutine practice and in-hospital education will be given to the very low birth weight infants and parents. All care measures will be led by the nursing staff, without the participation of parents. | Behavioural | Routine nursing care group |
Primary outcome
Changes on the level of Melatonin in very low birth weight infants
Time frame: From baseline to day 21 after the implementation of Family integrated care intervention
At 32 weeks of corrected gestational age (baseline) and day 21 after the implementation of FICare intervention, melatonin will be quantitatively measured by high performance liquid chromatography-mass spectrometry (HPLC-MS) with saliva samples collected by a specially-assigned person.
6 secondary outcomes
Breast feeding rate
Time frame: At the day 21 after the implementation of Family integrated care intervention
Changes in maternal milk volume
Time frame: From baseline to day 21 after the implementation of Family integrated care intervention
Rate of weight gain
Time frame: From baseline to day 21 after the implementation of Family integrated care intervention
Incidence of complications related to preterm birth
Time frame: Through study completion, about an average of 21 days
Length of hospitalization
Time frame: Through study completion, about an average of 21 days
Growth rate of head circumference
Time frame: From baseline to day 21 after the implementation of Family integrated care intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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.
Xiaojing Hu, PhD principal investigator
Children's Hospital of Fudan 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 Family integrated care intervention group and Routine nursing care group in people with Very Low Birth Weight Infant, run by Children's Hospital of Fudan University at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Aug 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang, Master (+8618071608186, 20211170025@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on the level of Melatonin in very low birth weight infants (time frame: From baseline to day 21 after the implementation of Family integrated care intervention). 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 14 Aug 2023.