Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants
Launched by FENERBAHCE UNIVERSITY · Jun 21, 2025
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a special type of care called kangaroo care—where a premature baby is held skin-to-skin on their mother’s chest—combined with the mother’s voice and a cozy fetal-like position, can help preterm infants feel more comfortable, grow better, and learn to feed by mouth more quickly. The study includes babies born between 30 and 34 weeks of pregnancy who are already getting all their nutrition through a feeding tube. Mothers who can read and write and agree to spend about an hour each day holding their baby skin-to-skin, while telling stories for part of that time, can take part in this study.
If eligible, babies will be randomly placed into two groups: one group will receive kangaroo care with maternal storytelling and special positioning, while the other group will receive only the special positioning without skin-to-skin contact. The study team will regularly check how comfortable the babies seem, measure their growth (like weight and length), and watch how well they transition to feeding by mouth. This study is important because it may show that simple, loving care from a mother can improve the health and feeding success of premature babies. Mothers who cannot or do not want to do kangaroo care will still receive the standard care. Certain babies, such as those with serious medical conditions or needing breathing machines, are not included in this study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Infants with a gestational age between 30-34 weeks.
- • 2. The mother's ability to read and write.
- • 3. The infant must be fully enterally fed at the time of enrollment in the study.
- • 4. Infants who are being fed via orogastric tube at the time of enrollment.
- • 5. Infants whose mothers agree to engage in skin-to-skin contact for 1 hour, five sessions per week, with auditory stimulation (storytelling) for 15 minutes will be included in the study.
- • 6. Infants whose mothers cannot participate in the study (due to health issues or other reasons) or refuse kangaroo care will be placed in the control group, where routine service care will be applied.
- Exclusion Criteria:
- • 1. Presence of a congenital anomaly or genetic disease.
- • 2. Requirement of ventilator support.
- • 3. Infants receiving antibiotics for sepsis or suspected sepsis.
- • 4. Administration of sedative treatment.
- • 5. Having an intracranial hemorrhage greater than grade II.
- • 6. The mother having a physical condition that prevents skin-to-skin contact.
- • 7. The mother using substances or alcohol.
- • 8. Infants receiving IV fluid therapy.
About Fenerbahce University
Fenerbahçe University is a distinguished academic institution dedicated to advancing healthcare research through innovative clinical trials. Committed to fostering scientific excellence and interdisciplinary collaboration, the university aims to enhance patient outcomes and contribute to the broader medical community. With a focus on rigorous methodologies and ethical standards, Fenerbahçe University leverages its state-of-the-art facilities and expert faculty to conduct groundbreaking research that addresses critical health challenges and promotes evidence-based practices. Through its clinical trial initiatives, the university strives to translate research findings into tangible benefits for patients and society at large.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
İstanbul, , Turkey
Patients applied
Trial Officials
Canan GENÇ, Ph.D student
Principal Investigator
Fenerbahce University
Duygu Gözen, Ph.D
Study Chair
Koç University
NEGARIN Akbari, Ph.D
Study Chair
Fenerbahce University
Melek Selalmaz, Ms.c
Principal Investigator
ŞİŞLİ HAMİDİYE ETFAL TRAINING AND RESEARCH HOSPITAL
Ali Bulbul, Doctor
Principal Investigator
ŞİŞLİ HAMİDİYE ETFAL TRAINING AND RESEARCH HOSPITAL
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported