Impact of Breast Milk Timing on Infant Growth and Nutrient Absorption
Effect of Breast Milk Circadian Properties on Infant Growth Parameters and Nutrient Absorption in Preterm Newborns
This study is testing if feeding preterm babies breast milk at certain times can help them grow better and absorb more nutrients compared to regular feeding times.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 32 Weeks to 34 Weeks |
| Sex | All |
| Sponsor | Sakarya University Academic / other |
| Locations | 1 site (Karaman) |
| Trial ID | NCT06342674 on ClinicalTrials.gov |
What this trial studies
This study investigates how the timing of breast milk expression, aligned with the infant's circadian rhythm, affects growth parameters and nutrient absorption in preterm newborns. It involves healthy mothers who express their milk regularly and have infants in the neonatal intensive care unit. The research aims to determine if feeding infants breast milk at specific times can enhance their growth and nutrient uptake compared to usual care. The study is designed as a randomized controlled trial to provide robust evidence on this topic.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy mothers of preterm infants who are unable to breastfeed and regularly express their milk.
Not a fit: Patients who are full-term infants or those whose mothers have health issues that prevent them from participating will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could optimize growth and nutrient absorption in preterm infants, improving their overall health outcomes.
How similar studies have performed: While there is limited research specifically on the circadian properties of breast milk, studies on breast milk composition and infant nutrition have shown promising results, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The mother is healthy (without a history of preeclampsia, hypertension, diabetes, hepatitis B or C, HIV, tuberculosis, mastitis or oncological disease) * The mother's birth is 32-34 between weeks of gestation * The mother does not follow a special diet * The mother is not a vegetarian * The mother does not smoke * The mother must have a body mass index within normal limits (BMI = 18.50-24.99) (WHO, 2022b) * Income must be at or above the monthly minimum wage * The mother cannot breastfeed her baby and routinely expresses her own milk every three hours. * The mother expresses her milk with a milking machine (milking will be done with the same brand device and the same level of suction power). * The baby is in the neonatal intensive care unit * Feeding the infant by gavage and oral method \*In order for the preterm newborn to be fed effectively and safely orally, it is necessary for the preterm baby to be able to coordinate sucking-swallowing as well as breathing (Tian et al., 2015). Gavage feeding is a priority in babies who have this coordination (TND, 2018). In babies who have the coordination of sucking, swallowing and breathing, oral feeding will be started after an assessment of readiness for oral feeding will be made. * Full enterally fed babies * The infant does not have a health problem that requires surgical treatment * 10th-90th percentile curves according to the infant's gestational age. percentile (those with normal birth weight for gestational age: Appropriate for Gestational Age -AGA) Exclusion Criteria: * The mother receives medication (antibiotics, etc.) treatment * Interruption of the mother's milk during the working period * Low birth weight of the baby according to the intrauterine growth curve * Feeding the baby with formula * Total parenterally fed babies * The baby has a small birth weight for the gestational age (Small for Gestational Age - SGA) and a baby with a large birth weight for the gestational age (LGA). Criteria for Exclusion from the Study; * The mother received medication (antibiotics, etc.) during the data collection process. * The mother does not want to continue * Respiratory problems, hypoglycemia, hyperbilirubinemia, etc. in preterm babies. occurrence of various problems
Where this trial is running
Karaman
- Karamanoğlu Mehmet Bey University — Karaman, Turkey (Recruiting)
Study contacts
- Principal investigator: Ayşe Sonay Türkmen, Prof. Dr. — Karamanoğlu Mehmet Bey University
- Study coordinator: Nejla Canbulat Şahiner, Prof.Dr.
- Email: ncanbulat@kmu.edu.tr
- Phone: +90 (338) 226 20 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.