PrematurityNCT07908966
Rectal Administration of Mother's Own Milk and Growth in Preterm Infants
An observational study of Prematurity and Delayed Passage of Meconium, run by Azerbaijan Medical University at 1 site in Azerbaijan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 2 days
- Conditions the study is for
- Prematurity, Delayed Passage of Meconium, Feeding Intolerance
- What is being tested?
- Rectal Administration of Mother's Own Milk
- How many people
- 50 participants
- Where
- 1 siteAzerbaijan
- Study dates
- 1 Jan 2023to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 days
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- Preterm infants born between 27+0 and 32+6 weeks of gestation.
- Requirement for orogastric tube feeding due to insufficient oral feeding ability.
- Absence of meconium passage within the first 48 hours after birth.
- Birth during the study period from January 1, 2023, to January 31, 2026.
Who cannot join
- Major congenital or chromosomal abnormalities.
- Gastrointestinal malformations or gastrointestinal surgery.
- Incomplete medical records.
- Loss to follow-up before 40 weeks' postmenstrual age.
Trial locations and contacts
1 site in 1 country.
Azerbaijan1 site
Educational Surgery Clinic of Azerbaijan Medical University
Baku, AZ1022
About this study
Official title: Rectal Administration of Mother's Own Milk in Preterm Infants: Feeding Progression and Growth to Term-Equivalent Age in a Retrospective Cohort Study
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.
Read the detailed description
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.
- Being tested
- Rectal Administration of Mother's Own Milk
- Keywords
- Preterm Infants, Mother's Own Milk, Breast Milk Enema, Rectal Breast Milk Administration, Meconium Passage, Enteral Feeding, Neonatal Growth, Postmenstrual Age
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal Administration of Mother's Own MilkOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - RBM-Exposed Cohort | 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. Receives: Other: Rectal Administration of Mother's Own Milk | |
| Group 2 - Unexposed Control Cohort | Infants who met the same eligibility criteria but did not receive rectal administration of mother's own milk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From birth until full enteral feeding during neonatal hospitalization (up to 35 days).
Secondary outcomes (4)
Time to Full Oral Feeding
Number of days from birth until the infant completed all feeds orally for 24 consecutive hours without tube supplementation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 36 and 40 weeks' postmenstrual age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Jan 2023
- Primary completion31 Jan 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azerbaijan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarkhan Elbayiyev, Azerbaijan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908966
- Sponsor's protocol ID
- RBM-RETRO-2026-01
- Status last verified
- Nov 2026
- First submitted
- 21 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Administration of Mother's Own Milk in Preterm Infants: Feeding Progression and Growth to Term-Equivalent Age in a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07908966
- Acronym / sponsor ID
- RBM-RETRO-2026-01
- Keywords
- Preterm Infants, Mother's Own Milk, Breast Milk Enema, Rectal Breast Milk Administration, Meconium Passage, Enteral Feeding, Neonatal Growth, Postmenstrual Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azerbaijan Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - RBM-Exposed Cohort | – | Other: Rectal Administration of Mother's Own MilkInfants 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. |
| Group 2 - Unexposed Control Cohort | – | –Infants who met the same eligibility criteria but did not receive rectal administration of mother's own milk. |
Who may qualify
- Ages
- 0 to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (4 listed)
- Preterm infants born between 27+0 and 32+6 weeks of gestation.
- Requirement for orogastric tube feeding due to insufficient oral feeding ability.
- Absence of meconium passage within the first 48 hours after birth.
- Birth during the study period from January 1, 2023, to January 31, 2026.
Key exclusion criteria (4 listed)
- Major congenital or chromosomal abnormalities.
- Gastrointestinal malformations or gastrointestinal surgery.
- Incomplete medical records.
- Loss to follow-up before 40 weeks' postmenstrual age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal Administration of Mother's Own MilkInfants 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 | Other | Group 1 - RBM-Exposed Cohort |
Primary outcome
Time to Full Enteral Feeding
Time frame: From birth until full enteral feeding during neonatal hospitalization (up to 35 days).
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.
4 secondary outcomes
Time to Full Oral Feeding
Time frame: From birth until achievement of full oral feeding (up to 35 days).
Weight Z-Score at 36 and 40 Weeks' Postmenstrual Age
Time frame: At 36 and 40 weeks' postmenstrual age.
Length Z-Score at 36 and 40 Weeks' Postmenstrual Age
Time frame: At 36 and 40 weeks' postmenstrual age.
Head Circumference Z-Score at 36 and 40 Weeks' Postmenstrual Age
Time frame: At 36 and 40 weeks' postmenstrual age.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: 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.
Related trials for Prematurity
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity and Delayed Passage of Meconium, run by Azerbaijan Medical University at 1 site in Azerbaijan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Azerbaijan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Full Enteral Feeding (time frame: From birth until full enteral feeding during neonatal hospitalization (up to 35 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.