Clinical trial Recruiting at 1 site Interventional Ages 30 Weeks to 34 Weeks

Kangaroo care with a mother's voice and fetal positioning to help preterm babies feed and grow

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

Run by Fenerbahce University · NCT07045402 · Data updated 2026-11-12

This test tries daily skin-to-skin time with a mother's storytelling plus fetal positioning in preterm infants (30–34 weeks) to see if it improves comfort, growth, and the move to full oral feeding.

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Quick facts

Study typeInterventional
Ages30 Weeks to 34 Weeks
SexAll
Enrollment68 (estimated)
SponsorFenerbahce University
Academic / other
Locations1 site (Istanbul)
StatusRecruiting
StartedFebruary 10, 2025
Main results expectedFebruary 10, 2026
Study endsMarch 10, 2026
Registry record updatedSeptember 4, 2025
Trial IDNCT07045402 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Eligible infants are 30–34 weeks gestation, clinically stable and fully enterally fed (including those on orogastric tubes) whose mothers can read, consent, and provide one-hour skin-to-skin sessions with 15 minutes of storytelling at least five days per week.

Probably not a fit

Infants requiring ventilator support, receiving antibiotics for sepsis, on sedatives, with major congenital/genetic conditions, or with intracranial hemorrhage > grade II — and infants whose mothers cannot participate — are excluded and unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study will enroll clinically stable preterm infants born at 30–34 weeks gestation and assign them to either an intervention group receiving one hour of kangaroo care with maternal storytelling followed by lateral fetal positioning, or a control group receiving routine incubator fetal positioning alone. The intervention occurs at least five days per week, with comfort measured by the Neonatal Comfort Behavior Scale before feeding, after kangaroo care, and after positioning; growth measures (weight, length, head circumference) are also recorded. Data collection is performed during daytime hours and continued until infants reach full oral feeding. The protocol excludes infants with major congenital anomalies, ventilator dependence, active sepsis treatment, high-grade intracranial hemorrhage, or exposure to sedative therapy.

Why it matters

Potential benefit: If effective, the approach could help preterm infants become more comfortable, gain weight more steadily, and reach full oral feeding sooner, shortening hospital stays and improving early bonding.

How similar studies have gone: Prior research has shown kangaroo care and maternal voice can improve thermoregulation, comfort, and parent–infant bonding and has been associated with improved feeding outcomes, but combining maternal storytelling with scheduled kangaroo care and standardized fetal positioning is less well studied.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Fenerbahce University
    Istanbul, Turkey (Türkiye)
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.