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Search / Trial NCT07045402

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.

Locations

İstanbul, , Turkey

Patients applied

0 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