Can family care boost preterm baby outcomes? new study investigates
NCT ID NCT07364903
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether training and involving families in the care of preterm and low-birth-weight babies in hospital units can improve outcomes like shorter hospital stays and better weight gain. Over 1,000 newborns in Ethiopia will take part, with some hospitals using family-integrated care and others standard care. The goal is to see if this low-cost approach helps babies in resource-limited settings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Family Integrated Newborn Care (behavioral intervention: training, mentoring, and integrating families into care)
- What this could lead to
- If successful, this could show that family involvement in newborn care units improves survival and weight gain for preterm babies in low-resource settings.
- What could go wrong
- This is a quasi-experimental study, not a randomized trial, so results may be less reliable. It is also limited to one region in Ethiopia, so findings may not apply elsewhere.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,020 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * All neonates aged 0-28 days admitted to level-2 NCUs in the neonatal care unit, including Kangaroo Mother care ward or mothers' side ward, with conditions that require hospital stay at 48 hours; and * accompanied by at least one parent (preferably a mother) dedicated to spending up to 8 hours per day with the infant Exclusion Criteria: * Neonates with major congenital anomalies * Infants with no family member to accompany the infant, or who do not consent to spend up to 8 hours per day in the NCU * Families with confirmed physical and/or mental problems limiting their capability to communicate and to engage, or those who leave against medical advice
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital
RECRUITINGMek'ele, Tigray, 1871, Ethiopia
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Mekelle General Hospital, Wukro General Hospital and Adigrat General Hospital
NOT_YET_RECRUITINGMek'ele, Tigray, 1871, Ethiopia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can involving families in hospital care respect patient rights?
- Ultrasound may help doctors time lifesaving lung treatment for preterm infants
- NICU study: does more time with parents help preterm babies thrive?
- New NICU training aims to ease parents' anxiety and improve care
- Letting parents join NICU rounds boosts care quality, study finds
- Cord blood transfusions could be safer for preterm babies