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

Study acronym: KCareInfant
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 4, 2025 (before its estimated February 10, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Eligibility criteria shortened, about 5 wordsv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07045402
Lead Sponsor Fenerbahce University
Conditions
(from sponsor)		 Infant, Premature, Kangaroo Mother Care, Comfort, Feeding, Oral Feeding Performance, Facilitated Tucking
Related terms Premature Birth
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov