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A gentle touch: can tailored care rewire the brains of tiny preterm babies?

NCT ID NCT00914108

Knowledge-focused Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study tests whether a family-centered developmental care program, called NIDCAP, can improve brain and behavior outcomes in preterm infants born with severe intrauterine growth restriction. The intervention involves weekly observations of each infant's behavior, with personalized suggestions for parents and staff on how to support the baby's development. Researchers will assess the infants' neurobehavioral and brain activity (via EEG) to see if this individualized care makes a difference. The goal is to understand if focusing on the infant's cues can positively influence their long-term development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Newborn Individualized Developmental Care (NIDCAP), a behavioral intervention involving weekly neurobehavioral observations and tailored guidance for parents and staff
What this could lead to
If effective, this approach could improve long-term neurodevelopmental outcomes for preterm infants born with severe growth restriction, offering a low-risk, non-drug way to support their development.
What could go wrong
This is a small, early-stage study with only 30 participants, so results may not apply broadly. The intervention is behavioral and depends on consistent implementation, and benefits may be modest or hard to measure.

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

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

30 people

The number who actually took part.

Start date

Oct 1996

Finished

Jul 2002

Lead sponsor

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

Up to 36 weeks

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Inborn at the Brigham and Women's Hospital * Gestational age \< 36 weeks * Birthweight \< 5th percentile * Head circumference at birth \< 5th percentile Exclusion Criteria: * Presence of major chromosomal or congenital anomalies (Down's, Turner's, Klinefelter's Syndrome, etc.) * Presence of major congenital infections (HIV, TORCH) * Presence of significant prenatal focal brain lesions (intrauterine infarcts; cystic changes, etc.) * Presence of major maternal illness (uncontrolled diabetes, active seizure disorder requiring medication during pregnancy, renal transplant), mental and/or emotional impairment (including heroin addiction and documented alcoholism)

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Conditions

The condition(s) this trial relates to.

fetal growth restriction Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intrauterine growth retardation Prematurity

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Boston

    Boston, Massachusetts, 02115, United States

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