NCT07045402 Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants
| NCT ID | NCT07045402 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fenerbahce University |
| Condition | Infant, Premature |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2026-02-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2025-02-10 with a primary completion date of 2026-02-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Infants with a gestational age between 30-34 weeks. 2. The mother's ability to read and write. 3. The infant must be fully enterally fed at the time of enrollment in the study. 4. Infants who are being fed via orogastric tube at the time of enrollment. 5. 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. 6. 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. Exclusion Criteria: 1. Presence of a congenital anomaly or genetic disease. 2. Requirement of ventilator support. 3. Infants receiving antibiotics for sepsis or suspected sepsis. 4. Administration of sedative treatment. 5. Having an intracranial hemorrhage greater than grade II. 6. The mother having a physical condition that prevents skin-to-skin contact. 7. The mother using substances or alcohol.
Contact & Investigator
Canan GENÇ, Ph.D student
PRINCIPAL INVESTIGATOR
Fenerbahce University
Frequently Asked Questions
Who can join the NCT07045402 clinical trial?
This trial is open to participants of all sexes, aged 30 Weeks or older, up to 34 Weeks, studying Infant, Premature. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07045402 currently recruiting?
Yes, NCT07045402 is actively recruiting participants. Contact the research team at negarin.akbari@fbu.edu.tr for enrollment information.
Where is the NCT07045402 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07045402 clinical trial?
NCT07045402 is sponsored by Fenerbahce University. The principal investigator is Canan GENÇ, Ph.D student at Fenerbahce University. The trial plans to enroll 68 participants.