Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fenerbahce University
Istanbul, Turkey (Türkiye)
Actively Recruiting
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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