Actively Recruiting

Phase Not Applicable
Age: 30Weeks - 34Weeks
All Genders
Healthy Volunteers
NCT07045402

Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants

Led by Fenerbahce University · Updated on 2025-09-04

68

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized controlled study aims to evaluate the effects of kangaroo care combined with maternal voice and fetal positioning on the comfort, growth, and transition to full oral feeding in preterm infants aged 30 to 34 weeks gestation. After ethical approval, eligible infants in the neonatal clinic will be randomly assigned to either the intervention group receiving kangaroo care, maternal voice, and fetal positioning, or a control group receiving only fetal positioning in the incubator. The intervention involves daily one-hour kangaroo care sessions with maternal storytelling, followed by positioning in the lateral fetal posture, continuing at least five days per week until infants achieve full oral feeding. Infant comfort will be assessed regularly using the Neonatal Comfort Behavior Scale before feeding, immediately after kangaroo care, and after fetal positioning. Growth parameters, including weight, length, and head circumference, will be measured and recorded on kangaroo care days. The control group will receive routine fetal positioning without kangaroo care, with identical measurements taken. The study aims to determine whether kangaroo care combined with maternal voice and fetal positioning improves infant comfort, supports growth, and facilitates the transition to full oral feeding in preterm newborns.

CONDITIONS

Official Title

Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants

Who Can Participate

Age: 30Weeks - 34Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants with a gestational age between 30-34 weeks
  • Mother is able to read and write
  • Infant is fully enterally fed at enrollment
  • Infant is fed via orogastric tube at enrollment
  • Mother agrees to provide skin-to-skin contact for 1 hour, five sessions per week, with 15 minutes of storytelling
  • Infants whose mothers cannot participate or refuse kangaroo care will be placed in the control group
Not Eligible

You will not qualify if you...

  • Presence of congenital anomaly or genetic disease
  • Need for ventilator support
  • Receiving antibiotics for sepsis or suspected sepsis
  • Receiving sedative treatment
  • Intracranial hemorrhage greater than grade II
  • Mother has physical condition preventing skin-to-skin contact
  • Mother uses substances or alcohol

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fenerbahce University

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

N

Negarin Akbari, Ph.D

CONTACT

D

Duygu GÖZEN, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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