Could a drop of breast milk ease needle pain in premature babies?

NCT ID NCT07716813

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Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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
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First seen Jul 21, 2026 · Last updated Aug 26, 2026 · Updated 4 times

Summary

This study compares giving premature infants a small amount of breast milk, 10% dextrose, or 20% dextrose by mouth, along with gentle positioning, during a routine heel prick blood test. The goal is to see which approach best reduces pain and stabilizes heart rate, breathing, and oxygen levels. The trial enrolls stable preterm babies born between 33 and 37 weeks who are less than a week old.

What this could mean

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

Active substance
oral breast milk or dextrose solution (10% or 20%) given with supportive positioning
What this could lead to
If effective, this could provide a simple, drug-free way to reduce pain and stress in premature infants during routine blood tests.
What could go wrong
This is a small, early-stage trial with 96 infants, so results may not apply broadly. Pain is subjective and hard to measure in newborns, and the effects may be modest.

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 96 people

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

Started

Jul 2026

Expected to finish

Sep 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

32 weeks to 37 months

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: * Parental consent for the baby's participation in the study * Admission to Mersin University Hospital NICU between July 16, 2026 and December 30, 2026, * Gestational age at birth between 33 weeks and 37 weeks, * Postnatal age less than 7 days, * Heel prick blood test planned within the scope of NTP, * Stable clinical condition, * Absence of genetic or metabolic problems, * Developed sucking-swallowing and breathing coordination, * Having been fed at least 30 minutes before the procedure, * No experience with invasive procedures in the last 6 hours before the procedure, * No administration of non-opioid analgesics in the last 4 hours before the procedure, * No administration of opioid analgesics and sedative agents in the last 24 hours before the procedure, * Spontaneous respiration at 21% FiO2, * Absence of neurological problems (e.g., asphyxia, hypoxic ischemic encephalopathy, intraventricular hemorrhage, periventricular leukomalacia, spinal cord injury…), * Absence of contraindications to oral glucose/breast milk administration (e.g., necrotizing enterocolitis or suspicion thereof, feeding intolerance, tracheoesophageal fistula, absence of esophageal atresia…), * Absence of endocrine problems (e.g., hypoglycemia, hyperglycemia, large for gestational age, absence of a diabetic mother…), Exclusion Criteria: * Parental disapproval of infant's participation in the study * No hospitalization at Mersin University Hospital NICUs between July 16, 2026 and December 30, 2026, * Gestational age at birth less than 33 weeks or greater than 37 weeks, * Postnatal age greater than 7 days, * Heel prick blood test not planned within the scope of NTP, * Clinical condition not stable, * Lack of developed sucking-swallowing and breathing coordination, * Having been fed within 30 minutes of the procedure, * Having had invasive procedures experience in the last 6 hours before the procedure, * Having received non-opioid analgesics in the last 4 hours before the procedure, * Having received opioid analgesics and sedative agents in the last 24 hours before the procedure, * Genetic or metabolic problem The following are contraindications: * Being on invasive or non-invasive mechanical ventilation support, * Having a neurological problem, * Oral glucose/breast milk administration being contraindicated, * Having an endocrine and metabolic problem.

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Conditions

The condition(s) this trial relates to.

agnosia Pain Premature Birth

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Mersin University

    RECRUITING

    Mersin, 33343, Turkey (Türkiye)

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