Very Low Birth Weight InfantNCT06550440
The Impact of Family Integrated Care on Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants
An observational study of Very Low Birth Weight Infant, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants. Read more about this study
- Who is it for?
- Ages 28 to 32 weeks
- Conditions the study is for
- Very Low Birth Weight Infant
- What is being tested?
- family integrated care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,255 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 1 May 2024
- Phase
- Observational
- 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 28 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: very low birth weight infants
Who may be able to join
- Newborns admitted to 17 units in 8 provinces from February 2021 to November 2023;
- Birth weight < 1500 g, gestational age < 32 weeks;
- admitted in NICU within 24 hours after birth;
- premature infants without complications (including bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, intraventricular hemorrhage and late-onset septicemia) at the time of admission.
Who cannot join
- death occurred during hospitalization;
- Incomplete outcome data (lack of EUGR data at discharge).
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: The Impact of Family Integrated Care on the Occurrence of Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants: a Multicenter, Retrospective Case-control Study
To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.
Read the detailed description
To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.Very low birth weight infants admitted to 17 neonatal intensive care units in 8 provinces and cities in southeast China from February 2021 to November 2023 were retrospectively included, which were divided into case group and control group according to whether there was extrauterine growth restriction (defined as the weight below the 10th percentile of children of the same age at discharge). The general situation at birth, the length of hospital stay, the incidence of complications during hospital stay, the feeding situation, the length of family participation care and the perinatal situation of the mother were compared between the two groups. The generalized linear mixed model was used to analyze the influencing factors of extrauterine growth retardation at discharge, and the results of influencing factors were visualized by GraphPad Prism 9.0 software.
- Conditions
- Very Low Birth Weight Infant
- Being tested
- family integrated care
- Keywords
- very low birth weight infants, family integrated care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family integrated careBehavioural
Trained NICU nurses give effective education to parents of children, and regard parents as a part of NICU team, so that they can actively provide positive care for babies instead of passive caregivers. Parents mainly participate in nursing care such as bottle feeding, changing diapers, skin contact and so on.
| Study group | Role | What they receive |
|---|---|---|
| the control group | Very low birth weight infants without extrauterine growth restriction at discharge. Receives: Behavioral: family integrated care | |
| the case group | Very low birth weight infants with extrauterine growth restriction at discharge. Receives: Behavioral: family integrated care |
What is being measured
The primary outcome is the main question the study is designed to answer.
total duration of family integrated care
Trained NICU staffs effectively educate parents as part of the NICU team so that they can proactively provide active care for the baby, rather than passive caregivers. Parents are primarily involved in care such as bottle feeding, diaper changing, skin-to-skin contact and so on.We calculate total duration of family integrated care in hours.
Measured: From the day admitted into the NICU until day on discharge，an average of 2 months.
Secondary outcomes (4)
Birth weight
birth weight in grams
Measured: assessed at birth.
Small for gestational age
birth weight<10th percentile of the neonatal growth curve for infants of the same sex and gestational age
Measured: assessed at birth.
Necrotizing enterocolitis
diagnosed according to the Bella classification
Measured: From the day admitted into the NICU until day on discharge, an average of 2 months.
gestational age
gestational age at weeks
Measured: assessed at birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Feb 2021
- Primary completion30 Nov 2023
- Study completion1 May 2024
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,255 participants (actual)
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
- NCT06550440
- Sponsor's protocol ID
- 20240712
- Status last verified
- Oct 2024
- First submitted
- 6 Aug 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qiu MF, Zhang Y, Tang YZ, Dou YL, Wang Y, Lyu TC, Fan QL, Ma YL, Li F, Rong H, Tang YF, Gu WW, Chen XC, Liu D, Wang H, Xiao J, Zhang LL, Wang Y, Ye RM, Li D, Li XX, Pang Y, Lin M, Lin M, Xuan Y, Hu XJ; Research Group of Developmental Care for Very Low Birth Weight Infants in China. An investigation into the impact of family integrated care on extrauterine growth restriction at discharge in very low birth weight infants: a multi-centre study. J Glob Health. 2025 Aug 11;15:04168. doi: 10.7189/jogh.15.04168.
PubMed 40785514
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Family Integrated Care on the Occurrence of Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants: a Multicenter, Retrospective Case-control Study
- ClinicalTrials.gov ID
- NCT06550440
- Acronym / sponsor ID
- 20240712
- Conditions
- Very Low Birth Weight Infant
- Keywords
- very low birth weight infants, family integrated care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,255 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 13 Aug 2024 (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.
To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.
Detailed description
To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.Very low birth weight infants admitted to 17 neonatal intensive care units in 8 provinces and cities in southeast China from February 2021 to November 2023 were retrospectively included, which were divided into case group and control group according to whether there was extrauterine growth restriction (defined as the weight below the 10th percentile of children of the same age at discharge). The general situation at birth, the length of hospital stay, the incidence of complications during hospital stay, the feeding situation, the length of family participation care and the perinatal situation of the mother were compared between the two groups. The generalized linear mixed model was used to analyze the influencing factors of extrauterine growth retardation at discharge, and the results of influencing factors were visualized by GraphPad Prism 9.0 software.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the control group | – | Behavioral: family integrated careVery low birth weight infants without extrauterine growth restriction at discharge. |
| the case group | – | Behavioral: family integrated careVery low birth weight infants with extrauterine growth restriction at discharge. |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- very low birth weight infants
Key inclusion criteria (4 listed)
- Newborns admitted to 17 units in 8 provinces from February 2021 to November 2023;
- Birth weight < 1500 g, gestational age < 32 weeks;
- admitted in NICU within 24 hours after birth;
- premature infants without complications (including bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, intraventricular hemorrhage and late-onset septicemia) at the time of admission.
Key exclusion criteria (2 listed)
- death occurred during hospitalization;
- Incomplete outcome data (lack of EUGR data at discharge).
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 careTrained NICU nurses give effective education to parents of children, and regard parents as a part of NICU team, so that they can actively provide positive care for babies instead of passive caregivers. Parents mainly participate in nursing care such as bottle feeding, changing diapers, skin contact and so on. | Behavioural | the case group, the control group |
Primary outcome
total duration of family integrated care
Time frame: From the day admitted into the NICU until day on discharge，an average of 2 months.
Trained NICU staffs effectively educate parents as part of the NICU team so that they can proactively provide active care for the baby, rather than passive caregivers. Parents are primarily involved in care such as bottle feeding, diaper changing, skin-to-skin contact and so on.We calculate total duration of family integrated care in hours.
4 secondary outcomes
Birth weight
Time frame: assessed at birth.
Small for gestational age
Time frame: assessed at birth.
Necrotizing enterocolitis
Time frame: From the day admitted into the NICU until day on discharge, an average of 2 months.
gestational age
Time frame: assessed at birth.
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 21 Oct 2024.
- Derived from this study: PubMed 40785514Qiu MF, Zhang Y, Tang YZ, Dou YL, Wang Y, Lyu TC, Fan QL, Ma YL, Li F, Rong H, Tang YF, Gu WW, Chen XC, Liu D, Wang H, Xiao J, Zhang LL, Wang Y, Ye RM, Li D, Li XX, Pang Y, Lin M, Lin M, Xuan Y, Hu XJ; Research Group of Developmental Care for Very Low Birth Weight Infants in China. An investigation into the impact of family integrated care on extrauterine growth restriction at discharge in very low birth weight infants: a multi-centre study. J Glob Health. 2025 Aug 11;15:04168. doi: 10.7189/jogh.15.04168.
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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?
An observational study of 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 4 inclusion and 2 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 21 Oct 2024. 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?
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?
total duration of family integrated care (time frame: From the day admitted into the NICU until day on discharge，an average of 2 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 NCT06550440, 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 21 Oct 2024.