Could a drop of breast milk ease needle pain in premature babies?
NCT ID NCT07716813
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
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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
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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32 weeks to 37 months
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mersin University
RECRUITINGMersin, 33343, Turkey (Türkiye)
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