New study aims to cut SIDS risk in preterm infants with simple sleep training
NCT ID NCT07420686
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests two ways to help parents of preterm babies follow safe sleep guidelines. One approach trains NICU staff to model and teach safe sleep. The other sends parents text or video messages after discharge. 1,600 mothers across 16 hospitals will take part. The goal is to see if these methods increase the number of babies sleeping on their backs, in a crib, without loose bedding, and in the parents' room but not in the adult bed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- behavioral intervention (NICU staff training and mobile health videos)
- What this could lead to
- If successful, this could provide a practical, nationwide program to reduce the risk of sudden infant death in preterm babies.
- What could go wrong
- This is a behavioral study, not a drug trial, so results depend on parents following recommendations. The study hasn't started yet, and effects may vary by family.
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 1,600 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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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13 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * English- or Spanish- speaking mothers of preterm infants (gestational age \<37 weeks' weeks) * Infant must have been admitted to one of the 16 participating NICUs for at least 7 days * Infant must be discharged home from one of the 16 participating NICUs within 56 weeks post-menstrual age (\>95% of preterm infants) * Infant must be discharged to the care of the mother (not a foster family) who intends to care for the child in the US for the first 6 months post-discharge * Must have a phone that can receive text messages and view videos Exclusion Criteria: * Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process. * Infant has contraindications to safe sleep positioning (e.g. extremely rare conditions of the airway or lower spine) * Meets the definition of a minor according to applicable state law.
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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
1 site. 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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University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01545, United States
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