Paternal gentle touch to improve newborn feeding, comfort, and blood sugar
The Effect of Paternal Touch on Sucking Performance, Comfort, and Glucose Levels in Newborns at Risk for Hypoglycemia During the First Hours of Life
This will try gentle hand touch by fathers during the first six hours to see if it improves sucking, comfort, and blood glucose in newborns at risk for low blood sugar.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 1 Hour to 6 Hours |
| Sex | All |
| Sponsor | Acibadem University Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07302412 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial assigns clinically stable newborns at risk for hypoglycemia to either standard care or a paternal Gentle Human Touch protocol in the first six hours after birth. Fathers in the intervention group provide 15-minute gentle touch sessions every hour for six hours while feeding and comfort are observed, and the control group receives standard care. Outcomes include sucking performance measured by the LATCH tool, comfort measured by the Neonatal Comfort and Behavior Scale, and serial blood glucose measurements. Trained nurses and independent observers perform the assessments to support objective comparison between groups.
Who should consider this trial
Good fit: Ideal candidates are clinically stable newborns identified as being at risk for hypoglycemia whose fathers are present during the first six hours after birth and whose parents provide consent.
Not a fit: Newborns who develop hypoglycemia during the study period, require hypoglycemia treatment, have congenital anomalies, or whose fathers are unavailable are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, paternal gentle touch could improve early breastfeeding success, increase newborn comfort, and help maintain healthier blood glucose levels in infants at risk for hypoglycemia.
How similar studies have performed: Previous small studies in preterm and term infants suggest Gentle Human Touch can reduce stress responses and improve physiological parameters, but paternal-specific touch for feeding performance and glucose regulation is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborns identified as being at risk for hypoglycemia (see study population). * Newborns whose parents/legal guardians have provided written informed consent. * Clinically stable newborns who have no contraindications to breastfeeding during the first 6 hours after birth. * Newborns whose fathers are present during the first 6 hours after birth. Exclusion Criteria: * Newborns who develop hypoglycemia during the study period or who require initiation of hypoglycemia treatment. * Newborns with congenital anomalies or a diagnosed genetic syndrome.
Where this trial is running
Istanbul, Istanbul
- Acibadem University Atakent Hospital — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: semra Kucuk, lecturer
- Email: semra.kucuk@acibadem.edu.tr
- Phone: 05304154860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.