NCT05503238

The Effects of Mother-infant Skin-to-skin Contact on Stress Response of Preterm Infants

The Effects of Mother-infant Skin-to-skin Contact on Cumulative Stress of Preterm Infants in the Neonatal Intensive Care Unit : A Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 0 Hours – 24 Hours
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effect of maternal-infant skin-to-skin contact (SSC) versus routine care on general stress in preterm infants in the neonatal intensive care unit (NICU).

Detailed description

Primary outcome of this trial to investigate the effects daily skin-to-skin contact on cumulative stress through measures salivary cortisol. The intervention group will receive mother-infant skin-to-skin contact at least 1 continuous hour everyday from infant 3 days of life until discharge. The control group will receive routine neonatal care during hospitalization except skin-to-skin contact. The concentration of salivary cortisol and other infant and parental outcomes will be measured in both groups.

Conditions

• Preterm Infant

Interventions

Type	Name	Description
BEHAVIORAL	Skin-to-skin contact	Preterm infants will receive maternal-infant skin-to-skin contact at least 1 continuous hour everyday from infant 3 days of life until discharge, and other nursing care will be same as the routine group. During skin-to-skin contact, place naked baby only with diaper on the mother's bare chest in an upright position and tilt the baby's head to one side in a slightly extended position to keeps the airway open, cover the infant with a blanket to keep them warm. A neonatal nurse will be stay with mother and infant to observe and support.
OTHER	Routine care	Preterm infants will receive standard nursing care provided by neonatal nurses in accordance with hospital principles during hospitalization.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-05-31
• Completion: 2026-06-30
• First posted: 2022-08-16
• Last updated: 2025-02-24

Locations

1 site across 1 country: China