The Effect of Kangaroo Care and Maternal Voice on Comfort, Anthropometric Measurements, and Transition to Oral Feeding in Preterm Infants

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 months
Maximum Age: 7 months
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Turkey
Fenerbahce University
RECRUITING
Istanbul
Contact Information
Primary
Negarin Akbari, Ph.D
negarin.akbari@fbu.edu.tr
00905352679510
Backup
Duygu GÖZEN, Ph.D
duygu.gozen@iuc.edu.tr
05327065065
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2026-03-10
Participants
Target number of participants: 68
Treatments
Experimental: Kangaroo Care + Maternal Voice + Fetal Position Group
Infants in this group, once clinically stable, will receive kangaroo care with their mothers for one hour, at least five days a week, immediately after their enteral feeding until they transition to full oral feeding. During the first 15 minutes of skin-to-skin contact, the mother will tell a story to the infant. After the kangaroo care, the infants will be placed in an incubator, and a lateral fetal position will be maintained for half an hour. During this process, no intervention will be made unless necessary.~Until the infant transitions to full oral feeding, comfort will be assessed once a day, at least five days a week, using the Neonatal Comfort Behavior Scale: before feeding, immediately before finishing kangaroo care (at 60 minutes), and 30 minutes after the fetal position (at 90 minutes). On the days kangaroo care is applied, before feeding, the infant will be weighed using a ±10-gram sensitive digital baby scale, and their length and head circumference will be measured with
Active_comparator: Control Group: (Fetal Position group)
Infants in this group, whose mothers are unavailable, will receive only lateral fetal positioning for one and a half hours immediately after their enteral feeding, at least five days a week, until they transition to full oral feeding, in the incubator.~Until the infant transitions to full oral feeding, the same measurements will be taken and recorded as those for the Kangaroo Group.
Related Therapeutic Areas
Sponsors
Leads: Fenerbahce University

This content was sourced from clinicaltrials.gov