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New clamping method could save preterm brains

NCT ID NCT03808051

Disease control Sponsor: Leiden University 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new way of clamping the umbilical cord in very preterm babies (born before 30 weeks). Instead of clamping after a fixed time, doctors waited until the baby was stable—heart rate above 100 and oxygen levels normal. The goal was to see if this approach helps more babies survive without brain injury or severe gut problems. Over 680 infants took part across multiple hospitals.

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) – a procedure where the umbilical cord is clamped only after the infant is stable, rather than after a fixed time.
What this could lead to
If it works, this could become a new standard of care for very preterm births, reducing brain injury and death.
What could go wrong
The trial is completed but results are not yet widely confirmed. The procedure may be harder to perform in emergencies, and benefits may not apply to all preterm infants.

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

689 people

The number who actually took part.

Started

Jan 2019

Finished

May 2025

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 29 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: * Infants born at a gestational age below 30 weeks in a participating centre. * Parental consent (see 9.2). Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Significant congenital malformations influencing cardiopulmonary transition. * Signs of acute placental abruption. * Anterior placenta praevia or invasive placentation (accreta/percreta). * Birth by emergency caesarean section (ordered to be executed within 15 minutes). * Maternal general anaesthesia during caesarean section. * Twin gestation with signs of Twin Transfusion Syndrome or Twin Anaemia Polycythemia Syndrome not treated with fetoscopic laser treatment. * Multiple pregnancy \> 2 (triplets or higher order). * Decision documented to give palliative neonatal care. In case of twin delivery by caesarean section it is not possible to perform PBCC in both infants. Both infants will be included: the first infant will receive standard treatment and the second infant will be randomised to either PBCC or standard treatment.

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Birth, preterm Preterm infant

Contacts and locations

Locations

  • Amsterdam University Medical Centre, location AMC

    Amsterdam, Netherlands

  • Amsterdam University Medical Centre, location VU

    Amsterdam, Netherlands

  • Erasmus Medical Centre - Sophia Children's Hospital

    Rotterdam, Netherlands

  • Isala Clinics Zwolle

    Zwolle, Netherlands

  • Leiden University Medical Centre

    Leiden, Netherlands

  • Maastricht University Medical Centre

    Maastricht, Netherlands

  • Maxima Medical Centre

    Veldhoven, Netherlands

  • Radboud University Medical Centre

    Nijmegen, Netherlands

  • University Medical Centre Groningen

    Groningen, Netherlands

  • University Medical Centre Utrecht

    Utrecht, Netherlands

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