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Search / Trial NCT05651035

Effect of First Oral Feeding by the Mother on Preterm Infants' Feeding Performance and Physiological Symptoms

Launched by ISTANBUL UNIVERSITY - CERRAHPASA · Dec 6, 2022

Trial Information

Current as of January 13, 2025

Unknown status

Keywords

Preterm Infants Oral Feeding Breastfeeding Bottle Feeding Physiological Parameters

ClinConnect Summary

This clinical trial is studying how the method of first feeding affects preterm infants in the Neonatal Intensive Care Unit (NICU). Specifically, the researchers want to see if there are differences in weight gain and important health signs, like oxygen levels and heart rate, between babies who are breastfed by their mothers and those who are fed with a bottle by the nurses. The goal is to find out which feeding method helps the babies do better as they start eating on their own.

To be eligible for this study, infants should be born between 26 and 31 weeks of pregnancy and weigh at least 1500 grams when they join the study. They should also be ready to start oral feeding for the first time, and their parents must agree to participate. If a baby has certain health issues, like needing oxygen or specific medical conditions, they won't be able to join. Parents can expect to learn more about their baby's feeding progress and health during the trial, which is currently recruiting participants.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Gestation week at birth determined according to the mother's last menstrual date is 26-31+6 weeks,
  • Postmenstrual week at the time of the study was 32-39+6 weeks,
  • Having a body weight of 1500 grams or more at the time of inclusion in the study,
  • Suggested by the physician to switch to oral nutrition and switched from enteral nutrition to oral nutrition for the first time,
  • Breastfed,
  • Preterm infants whose parents' consent was obtained for inclusion in the study and whose parents signed the informed consent form
  • Exclusion Criteria:
  • Receiving oxygen,
  • Craniofacial anomalies such as cleft palate, cleft lip, facial muscle paralysis,
  • Preterm infants with any gastrointestinal, neurological and genetic disease (necrotizing enterocolitis, third and fourth level intracranial hemorrhage, periventricular leukomalacia, hydrocephalus, down syndrome, omphalocele, non-gastrodeia, short bowel syndrome and other diseases)

Trial Officials

Duygu Gözen, PhD

Study Director

Istanbul University - Cerrahpasa

About Istanbul University Cerrahpasa

Istanbul University - Cerrahpasa is a prestigious academic institution renowned for its commitment to advancing medical research and education. With a focus on innovative clinical trials, the university harnesses cutting-edge methodologies to address pressing health challenges. Its collaborative environment fosters interdisciplinary research, enabling the development of effective therapeutic strategies and enhancing patient care. The institution's dedication to ethical standards and patient safety underscores its reputation as a leader in clinical research within the region and beyond.

Locations

Avcılar, Istanbul, Turkey

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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