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Breast milk, sucking, and gentle holding: a new recipe to soothe newborn pain?

NCT ID NCT07777432

Symptom relief Sponsor: Universitat Jaume I 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether a combination of expressed breast milk, sucking, and facilitated tucking (gentle holding) reduces pain in healthy newborns during a heel prick, compared with breastfeeding alone. About 128 full-term infants will be randomly assigned to one of the two comfort methods. Pain will be measured using two validated scales, and crying time and heart rate will also be recorded.

What this could mean

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

Active substance
A non-pharmacological triple combination of expressed breast milk, sucking, and facilitated tucking, compared with breastfeeding (tetanalgesia), given during a heel prick procedure.
What this could lead to
If effective, this could offer a simple, drug-free way to reduce pain in newborns during routine procedures like heel pricks.
What could go wrong
This is a small, single-center trial, and the effect may be modest or not generalizable. Pain is subjective and hard to measure in newborns, so results may be uncertain.

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

128 people

The number who actually took part.

Started

Jan 2021

Finished

Mar 2023

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

47 to 52 hours

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: * Healthy term newborns with a gestational age of 37 weeks or later. * Breastfed newborns. * Newborns undergoing heel prick. * Written informed consent obtained from a parent or legal guardian. Exclusion Criteria: * Formula-fed newborns. * Newborns admitted to the pediatric unit for any medical condition.

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Conditions

The condition(s) this trial relates to.

agnosia Breast Feeding Pain

As listed by the trial registrant

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

Pain Pain management

Contacts and locations

Locations

  • Hospital Comarcal de Vinaròs

    Vinaròs, Castellón, 12500, Spain

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