Actively Recruiting
The Effect of Kangaroo Care and Maternal Voice on Comfort, Anthropometric Measurements, and Transition to Oral Feeding in Preterm Infants
Led by Fenerbahce University · Updated on 2025-09-04
68
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how kangaroo care combined with a mother's voice and fetal positioning affects comfort, growth, and the transition to full oral feeding in preterm infants born between 30 and 34 weeks gestation. This randomized controlled study compares infants receiving this combined intervention to those receiving only fetal positioning in an incubator. The study aims to determine if this approach improves infant comfort and supports growth during this critical period. Infants in the intervention group will receive daily one-hour kangaroo care sessions with maternal storytelling for the first 15 minutes, followed by 30 minutes in a lateral fetal position in the incubator. This will occur at least five days a week until the infants achieve full oral feeding. The control group will receive routine fetal positioning for one and a half hours after feeding without kangaroo care. Both groups will have comfort levels and growth measurements recorded regularly. Participants will be assessed daily using the Neonatal Comfort Behavior Scale before feeding, after kangaroo care, and following fetal positioning until full oral feeding is reached. Growth parameters including weight, length, and head circumference will be measured on kangaroo care days. The study will monitor comfort and feeding transition up to eight weeks, with measurements collected each morning between 08:00 and 16:00 during the study period. This detailed monitoring aims to assess the impact of the interventions on preterm infant outcomes.
CONDITIONS
Brief 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 and 34 weeks
- Mother is able to read and write
- Infant is fully enterally fed at the time of 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 storytelling for 15 minutes
- Infants whose mothers cannot participate or refuse kangaroo care will be placed in the control group
You will not qualify if you...
- Presence of a congenital anomaly or genetic disease
- Requirement of ventilator support
- Infant receiving antibiotics for sepsis or suspected sepsis
- Administration of sedative treatment
- Intracranial hemorrhage greater than grade II
- Mother has a 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Duration - Up to 8 weeks or until full oral feeding is achieved
Participants receive either kangaroo care with maternal voice and fetal positioning or fetal positioning alone after enteral feeding until they transition to full oral feeding. Comfort assessments and growth measurements are conducted regularly during this period.
At least 5 days a week with daily assessments before feeding, during, and after intervention
Trial Site Locations
Total: 1 location
1
Fenerbahce University
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
N
Negarin Akbari, Ph.D
D
Duygu GÖZEN, Ph.D
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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