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

Not Applicable

Withdrawn

• Conditions: Preterm Infant
• Interventions: Behavioral: Skin-to-skin contact; Other: Routine care

• Registration Number: NCT05503238
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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.

Study Timeline

• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-08-14
• Study First Posted: 2022-08-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Study Start: 2025-12-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 31 weeks≤gestational age<37 weeks;
• Birth weight ≥ 1500g;
• Admission age < 24h;
• No congenital malformations;
• Vital signs are stable and does not use ventilator and other auxiliary life support systems.

Exclusion Criteria

• Severe periventricular / intraventricular hemorrhage (grade III);
• Receiving sedation or vasopressor or analgesics opiodis and corticosteroids;
• Mother unable to communicate and communicate normally; Mother has a history of depression.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin-to-skin contact group	Skin-to-skin contact	Provide maternal-infant skin-to-skin contact for preterm infants in the neonatal intensive care unit.
Routine care group	Routine care	Perform routine nursing care for preterm infants in the neonatal intensive care unit.
Skin-to-skin contact group	Routine care	Provide maternal-infant skin-to-skin contact for preterm infants in the neonatal intensive care unit.

Primary Outcome Measures

Name	Time	Method
Changes on the concentration of cortisol of preterm infants	From 3 days of life (baseline) to 7 days of life	At 3 days of life (baseline) and 7 days of life, the saliva sample will collected from preterm infants by a neonatal nurse. The concentration of salivary cortisol will be measured using by radioimmunoassay.

Secondary Outcome Measures

Name	Time	Method
Crying time	At the preterm infants 7 days of life	At 7 days of life, crying time will be recorded and calculated by a neonatal nurse during heel lancet.
Length of hospital stays	Through study completion, an average of 40 days	Duration of hospitalization will calculate from the date of admission to the date of discharge, which obtained from clinical records files.
Changes on the level of cortisol during heel lancet	At the preterm infants 7 days of life	At 7 days of life, saliva sample will collected from preterm infants by a neonatal nurse before and 30 mins after heel lancet.
Score of Edinburgh Postnatal Depression Scale	Through study completion, an average of 40 days	Mothers' depression status will be measure by Edinburgh Postnatal Depression Scale through WeChat at discharge day. The questionnaire is a self screening tool, contains 10 items, each item is scored from 0-3 according to a 4-point Likert scale , and the total score is 0-30 points. The higher the score, the more severe the depression. All the questionnaires will collect and calculate by a neonatal nurse.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China