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Gentler resuscitation may protect fragile lungs in tiniest babies

NCT ID NCT01223274

Disease control Sponsor: NICHD Neonatal Research Network 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether using continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP) during resuscitation helps extremely low birth weight infants (born before 28 weeks) breathe better and avoid lung damage. Half of the babies receive standard care with 100% oxygen alone, while the other half get oxygen plus CPAP or PEEP through a facemask. The goal is to see if this gentler approach is feasible and reduces the need for breathing tubes and long-term ventilation.

What this could mean

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

Active substance
CPAP/PEEP (continuous positive airway pressure/positive end-expiratory pressure) via Neopuff device
What this could lead to
If this approach works, it could lead to better breathing support for the tiniest newborns, potentially reducing lung injury and the need for long-term ventilation.
What could go wrong
This is an early pilot study with only 104 infants, so results may not be conclusive. The intervention may not improve outcomes and could carry risks like lung overinflation or air leaks.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

104 people

The number who actually took part.

Start date

Jul 2002

Finished

Jan 2003

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 10 minutes

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: * Infants delivered in a specially equipped resuscitation room(s) * \<28 weeks gestational age by best obstetric estimate before delivery * Requiring resuscitation Exclusion Criteria: * No known major congenital anomalies * Decision made not to provide full resuscitation

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia fetal growth restriction Premature Birth

As listed by the trial registrant

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

Bronchopulmonary dysplasia Continuous positive airway pressure Infant, low birth weight Infant, newborn Infant, premature Infant, small for gestational age

Contacts and locations

Locations

  • Case Western Reserve University, Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106, United States

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio, 45267, United States

  • RTI International

    Durham, North Carolina, 27705, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California at San Diego

    San Diego, California, 92103-8774, United States

  • University of Miami

    Miami, Florida, 33136, United States

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