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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 26, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Skin-to-skin contact group
    • Provide maternal-infant skin-to-skin contact for preterm infants in the neonatal intensive care unit.
  • Other: Routine care group
    • Perform routine nursing care for preterm infants in the neonatal intensive care unit.

Clinical Trial Outcome Measures

Primary Measures

  • Changes on the concentration of cortisol of preterm infants
    • Time Frame: 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 Measures

  • Changes on the level of cortisol during heel lancet
    • Time Frame: 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
    • Time Frame: 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.
  • Length of hospital stays
    • Time Frame: 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.
  • Crying time
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • 31 weeks‚ȧgestational age<37 weeks; – Birth weight ‚Č• 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.

Gender Eligibility: All

Minimum Age: 0 Hours

Maximum Age: 24 Hours

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital of Fudan University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xiaojing Hu, Principal Investigator, Children’s Hospital of Fudan University
  • Overall Contact(s)
    • Wenjuan Han, Master, +8613020123256, hanxi1128@126.com

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