Clinical trial Recruiting at 1 site Interventional Ages 1 Hour to 6 Hours

Paternal gentle touch to improve newborn feeding, comfort, and blood sugar

Official title: The Effect of Paternal Touch on Sucking Performance, Comfort, and Glucose Levels in Newborns at Risk for Hypoglycemia During the First Hours of Life

Run by Acibadem University · NCT07302412 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages1 Hour to 6 Hours
SexAll
Enrollment98 (estimated)
SponsorAcibadem University
Academic / other
Locations1 site (Istanbul, Istanbul)
StatusRecruiting
StartedJanuary 5, 2026
Main results expectedDecember 8, 2027
Study endsDecember 8, 2027
Registry record updatedMarch 11, 2026
Trial IDNCT07302412 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

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

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Acibadem University Atakent Hospital
    Istanbul, Istanbul, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.