Breast milk and sugar solutions to ease heel-prick pain in premature babies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, parallel-group randomized trial will compare oral breast milk, 10% dextrose, and 20% dextrose administered with supportive positioning during routine heel lancing in premature NICU patients. Pain will be measured using standard pediatric pain assessment methods, with secondary outcomes including heart rate and oxygen saturation. The trial targets infants born between 33 and 37 weeks gestation, less than 7 days old, in the Mersin University Hospital NICU, and receiving a planned heel prick as part of newborn screening. A family-centered, developmental care approach will be used, with usual NICU nursing care and routine N-PASS pain assessment guiding procedures. The goal is to determine which intervention most effectively mitigates procedural pain and stabilizes physiologic parameters in this vulnerable population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mersin University
  Mersin, Turkey (Türkiye) Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.