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Could a gentler ICU environment boost brain development in heart babies?

NCT ID NCT05885113

Disease control 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a behavioral program called Individualized Developmental Care (NIDCAP) for newborns with complex congenital heart disease. The program aims to reduce stress from the hospital environment by supporting parent involvement, creating a soothing setting, and adjusting care to each infant's cues. Researchers will compare medical and developmental outcomes for infants who receive this care versus standard care, looking at hospital stay length, feeding, growth, and parent well-being.

What this could mean

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

Active substance
Individualized Developmental Care (NIDCAP)
What this could lead to
If effective, this approach could reduce developmental delays and improve long-term outcomes for infants with congenital heart disease.
What could go wrong
This is a small pilot study, so results may not apply broadly. The intervention requires staff training and may not be feasible in all hospitals.

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

34 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

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 4 months

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: * admitted to the Cardiac Intensive Care Unit (CICU) at Boston Children's Hospital (BCH) within 3 days of birth * diagnoses of complex CHD with need for open heart surgery within the first two weeks of life (for example: total anomalous pulmonary venous connection, transposition of the great arteries, truncus arteriosus, VSD with interrupted aortic arch) * free from associated extracardiac anomalies that are moderate or severe * free from previous cardiac surgery or associated cardiovascular anomalies * GA greater than 37 weeks * 1 and 5 minute Apgar ≥ 4 * free of known chromosomal and congenital abnormalities (e.g., Down syndrome, 22q11 deletion, Noonan syndrome, Williams syndrome) * free from multiple congenital anomalies (e.g., CHARGE syndrome) * mother's age ≥ 20 ≤ 45 years * absence of reported maternal alcohol, nicotine, or illegal drug use by maternal report and medical record review * telephone/internet access. Exclusion Criteria: * Patients who experience cardiac arrest, CPR, ECMO, or VAD prior to recruitment

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Conditions

The condition(s) this trial relates to.

congenital heart disease learning disability

As listed by the trial registrant

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

Cardiology Development delay Infant development

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.