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

Recruiting now · Not applicable

Conditions studied: Infant, Premature, Kangaroo Mother Care, Comfort, Feeding, Oral Feeding Performance, Facilitated Tucking

In brief

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.

Key facts

Study ID

NCT07045402

Run by

Fenerbahce University

People needed

68

Starts

2025-02-10

Expected to finish

2026-03-10

Last updated by the study team

2025-09-04

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Infants with a gestational age between 30-34 weeks.
• The mother's ability to read and write.
• The infant must be fully enterally fed at the time of enrollment in the study.
• Infants who are being fed via orogastric tube at the time of enrollment.
• 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.
• 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.

You may not qualify if…

• Presence of a congenital anomaly or genetic disease.
• Requirement of ventilator support.
• Infants receiving antibiotics for sepsis or suspected sepsis.
• Administration of sedative treatment.
• Having an intracranial hemorrhage greater than grade II.
• The mother having a physical condition that prevents skin-to-skin contact.
• The mother using substances or alcohol.

Where it is running

• Fenerbahce University — Istanbul, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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