An observational study in Prematurity, Delayed Passage of Meconium and Feeding Intolerance, sponsored by Azerbaijan Medical University. Completed at 1 site in Azerbaijan. Open to participants aged 0 Days to 2 Days. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Azerbaijan Medical University · Observational
This retrospective observational cohort study evaluated whether rectal administration of mother's own milk was associated with feeding progression and growth in preterm infants. The study included 50 infants born between 27+0 and 32+6 weeks of gestation at a neonatal intensive care unit in Baku, Azerbaijan, between January 2023 and January 2026. All infants had delayed meconium passage beyond 48 hours after birth.
Of the 50 infants, 29 received rectal administration of mother's own milk as part of clinical care, while 21 did not receive this intervention. Treatment was not randomly assigned. The primary outcome was time to full enteral feeding. Secondary outcomes included time to full oral feeding, hospital stay, and weight, length, and head circumference at 36 and 40 weeks' postmenstrual age.
The study aimed to explore whether this clinical practice was associated with improved feeding and growth outcomes and to provide preliminary evidence for future clinical trials.
This single-center retrospective pilot cohort study was conducted at the Educational Surgery Clinic of Azerbaijan Medical University in Baku, Azerbaijan. Medical records of preterm infants born between January 1, 2023, and January 31, 2026, were retrospectively reviewed.
Eligible infants were born at 27+0 to 32+6 weeks of gestation, required orogastric tube feeding, and had not passed meconium within the first 48 hours after birth. Infants with major congenital or chromosomal abnormalities, gastrointestinal malformations or surgery, incomplete medical records, or loss to follow-up before 40 weeks' postmenstrual age were excluded.
Infants were classified into two groups based on documented exposure to rectal administration of mother's own milk (RBM). The RBM group consisted of 29 infants who received freshly expressed maternal breast milk at a dose of 2 mL/kg, administered rectally once daily beginning 48 hours after birth and continuing until full enteral feeding was achieved. The control group consisted of 21 infants who did not receive RBM.
RBM administration was part of non-systematic clinical practice and was not assigned according to a prospective research protocol. There was no randomization or blinding.
The primary outcome was time from birth to full enteral feeding, defined as tolerance of 180 mL/kg/day of enteral nutrition for at least 24 consecutive hours. Secondary outcomes included time to full oral feeding, duration of neonatal intensive care unit hospitalization, and anthropometric measurements and z-scores at 36 and 40 weeks' postmenstrual age.
Data were retrospectively extracted from medical records. Statistical analyses accounted for gestational age, birth weight, sex, and clustering due to multiple births. The study was exploratory and intended to inform the design of future prospective randomized clinical trials.
The study received ethics approval from the Ethics Committee of TABIB, Azerbaijan (Approval No. 051/26, March 18, 2026). The requirement for informed consent was waived because of the retrospective design and use of anonymized medical records.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 50 is below the median of 120 across 806 observational studies indexed under Premature Birth.
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The study population consisted of preterm infants born at 27+0 to 32+6 weeks of gestation who required orogastric tube feeding and had not passed meconium within 48 hours after birth. Infants were treated at the Educational Surgery Clinic of Azerbaijan Medical University, Baku, Azerbaijan, between January 2023 and January 2026. Medical records were retrospectively reviewed. Of 50 infants included in the analysis, 29 had received rectal administration of mother's own milk and 21 had not received this treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Infants who received rectal administration of mother's own milk (2 mL/kg) once daily beginning 48 hours after birth until full enteral feeding was achieved.
Other: Rectal Administration of Mother's Own Milk
Infants who met the same eligibility criteria but did not receive rectal administration of mother's own milk.
Infants received freshly expressed mother's own milk (2 mL/kg), warmed to body temperature, administered rectally once daily beginning 48 hours after birth and continuing until full enteral feeding was achieved. The milk was slowly administered over approximately 2 minutes through an 8-Fr silicone catheter lubricated with olive oil and inserted approximately 2-3 cm into the rectum. This treatment was provided as part of routine clinical care and was not assigned according to a prospective research protocol. Kopyala
Time to Full Enteral Feeding
Number of days from birth until achievement of full enteral feeding, defined as tolerance of 180 mL/kg/day of enteral nutrition for at least 24 consecutive hours.
Time frame: From birth until full enteral feeding during neonatal hospitalization (up to 35 days).
Time to Full Oral Feeding
Number of days from birth until the infant completed all feeds orally for 24 consecutive hours without tube supplementation.
Time frame: From birth until achievement of full oral feeding (up to 35 days).
Weight Z-Score at 36 and 40 Weeks' Postmenstrual Age
Sex- and postmenstrual age-adjusted weight z-scores calculated using the INTERGROWTH-21st International Postnatal Growth Standards for Preterm Infants.
Time frame: At 36 and 40 weeks' postmenstrual age.
Length Z-Score at 36 and 40 Weeks' Postmenstrual Age
Sex- and postmenstrual age-adjusted length z-scores calculated using the INTERGROWTH-21st International Postnatal Growth Standards for Preterm Infants.
Time frame: At 36 and 40 weeks' postmenstrual age.
Head Circumference Z-Score at 36 and 40 Weeks' Postmenstrual Age
Sex- and postmenstrual age-adjusted head circumference z-scores calculated using the INTERGROWTH-21st International Postnatal Growth Standards for Preterm Infants.
Time frame: At 36 and 40 weeks' postmenstrual age.
Plan to share: Undecided — The decision regarding sharing de-identified individual participant data has not yet been finalized. Data sharing will be considered upon reasonable request to the corresponding author, subject to ethical approval, institutional policies, and applicable data protection regulations. Any data sharing will require appropriate safeguards to protect participant confidentiality.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Azerbaijan Medical University