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Could a simple saline enema save tiny preemies from deadly gut disease?

NCT ID NCT03631979

Disease control Sponsor: Uppsala County Council, Sweden 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tested whether giving extremely preterm babies (born before 27 weeks) a gentle saline enema twice a day could help them reach full feeding sooner and prevent necrotizing enterocolitis (NEC), a severe gut infection. The trial planned to include 200 infants but was terminated early, so the findings are limited. The approach is simple and low-cost, but its safety and effectiveness remain unproven.

What this could mean

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

Active substance
normal saline (salt water) given as an enema
What this could lead to
If it works, this simple, low-cost procedure could help extremely preterm babies tolerate feeding sooner and reduce the risk of a life-threatening gut infection.
What could go wrong
The trial was terminated early, so results are limited. The procedure may cause discomfort or injury in such fragile infants, and benefits are not proven.

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

200 people

The number who actually took part.

Started

Aug 2018

Finished

May 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

22 to 26 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: * born at Akademiska hospital in Uppsala * gestational age between 22 weeks + 0 days and 26 weeks +6 days * written informed consent obtained from both guardians before enrollment in the study. Exclusion Criteria: * major dysmorphic features consistent with chromosomal abnormality * major congenital anomalies, such as gastrointestinal disorders * circulatory instability during the first hours of life

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Conditions

The condition(s) this trial relates to.

necrotizing enterocolitis prevention target

As listed by the trial registrant

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

Necrotizing enterocolitis Time to full enteral nutrition

Contacts and locations

Locations

  • Neonatal intensiv care unit, 95F, Akademiska hospital

    Uppsala, 75185, Sweden

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