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Gentle holds may ease pain for preterm infants during tube insertion

NCT ID NCT03939169

Symptom relief Sponsor: Centre Hospitalier Régional Metz-Thionville 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether using supportive postures and holding techniques can lessen pain in premature babies when a feeding tube is placed through the nose into the stomach. The researchers planned to include babies born between 32 and 35 weeks, with or without their mother present. However, the study was stopped early with only 4 participants, so no clear conclusions can be drawn.

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

4 people

The number who actually took part.

Started

Nov 2019

Finished

Nov 2020

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Preterm baby born between the 32th and the 35th weeks of amenorrhea plus 6 days * Prescription of enteral nutrition via naso-gastric tube * Naso-gastric tube in-situ * Informed consent of both parents Exclusion Criteria: For the newborn * Under respiratory assistance * With nasal or buccal malformation * With abnormal heart rhythm or congenital heart disease * With hemodynamic instability * Transfer to type 3 neonatal unit * With a DAN score \> 0 before treatment * With an umbilical venous catheter in-situ * Fed with thickened milk * Prescription of analgesic medications For the parents * Minor * Under legal protection * Difficulties which do not permit the mother to carry out skin-to skin contact or holding support

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Conditions

The condition(s) this trial relates to.

Pain Premature Birth

As listed by the trial registrant

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

Premature infant

Contacts and locations

Locations

  • CHR Metz Thionville

    Metz, 57085, France

More trials for these conditions

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