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Timing of cord clamp could save lungs in rare birth defect

NCT ID NCT04373902

Disease control Sponsor: Erasmus Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether waiting to clamp the umbilical cord until after the baby's lungs have filled with air can reduce dangerous lung blood pressure (pulmonary hypertension) in newborns with congenital diaphragmatic hernia (CDH). About 140 infants with left-sided CDH will be randomly assigned to either immediate cord clamping or delayed clamping using a special trolley. The goal is to see if this simple timing change lowers the chance of severe lung problems in the first day of life.

What this could mean

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

Active substance
Physiological-based cord clamping (PBCC) procedure
What this could lead to
If it works, this simple change in how the umbilical cord is clamped could lower the risk of severe lung blood pressure problems in these fragile newborns.
What could go wrong
This is a relatively small, early-stage trial (140 infants). The procedure requires special equipment and may not be feasible in all delivery settings. Benefits seen in animal models may not translate to humans.

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

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2020

Expected to finish

Jul 2026

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

35 weeks and older

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: * Left-sided CDH * Isolated CDH: no associated structural or genetic abnormalities that are diagnosed before birth * Gestational age at delivery ≥35.0 weeks * Parental written informed consent Exclusion Criteria: * Right-sided or bilateral CDH * Gestational age at delivery \<35.0 weeks * Maternal contraindications: anterior placenta praevia, placental abruption * High urgency caesarean section, with intended interval to delivery \<15 min * Cases that have been treated during pregnancy with experimental drug therapy aiming to decrease the occurrence of pulmonary hypertension * Twin pregnancies in which the infant diagnosed with a CDH is born first * Multiple birth \>2 (triplets or higher order)

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities congenital diaphragmatic hernia Hernia, Diaphragmatic pulmonary hypertension

As listed by the trial registrant

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

Hernia; diaphragm defect, congenital Hernias, diaphragmatic, congenital Pulmonary hypertension

Contacts and locations

Locations

  • Erasmus MC University Medical Center - Sophia Children's Hospital

    Rotterdam, Netherlands

  • Karolinska University Hospital

    Stockholm, Sweden

  • Medical University Graz

    Graz, Austria

  • Monash University

    Melbourne, Australia

  • Ospedale Pediatrico Bambino Gesu

    Rome, Italy

  • Radboudumc University Medical Center

    Nijmegen, Netherlands

  • University Hospitals leuven

    Leuven, Belgium

  • Universitätsklinik Mannheim

    Mannheim, Germany

  • Universitätskrankenhaus Bonn

    Bonn, Germany

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