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

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).

Study Overview

• Status: Withdrawn
• Conditions: Preterm Infant
• Intervention / Treatment: Behavioral: Skin-to-skin contact; Other: Routine care

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 day (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skin-to-skin contact group; Provide maternal-infant skin-to-skin contact for preterm infants in the neonatal intensive care unit.	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.
Other: Routine care group; Perform routine nursing care for preterm infants in the neonatal intensive care unit.	Other: Routine care; Preterm infants will receive standard nursing care provided by neonatal nurses in accordance with hospital principles during hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on the concentration of cortisol of preterm infants	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.	From 3 days of life (baseline) to 7 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on the level of cortisol during heel lancet	At 7 days of life, saliva sample will collected from preterm infants by a neonatal nurse before and 30 mins after heel lancet.	At the preterm infants 7 days of life
Score of Edinburgh Postnatal Depression Scale	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.	Through study completion, an average of 40 days
Length of hospital stays	Duration of hospitalization will calculate from the date of admission to the date of discharge, which obtained from clinical records files.	Through study completion, an average of 40 days
Crying time	At 7 days of life, crying time will be recorded and calculated by a neonatal nurse during heel lancet.	At the preterm infants 7 days of life

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Principal Investigator: Xiaojing Hu, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 31, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Cortisol; Skin-to-skin contact; Stress response
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 2022 -31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No