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

NCT05503238 | Withdrawn

• 1 other identifier: 2022 -31
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Preterm Infant

Keywords

Stress response; Skin-to-skin contact; Cortisol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes on the level of cortisol during heel lancet

  At the preterm infants 7 days of life

• Score of Edinburgh Postnatal Depression Scale

  Through study completion, an average of 40 days

• Length of hospital stays

  Through study completion, an average of 40 days

• Crying time

  At the preterm infants 7 days of life

Study Arms (2)

Skin-to-skin contact group

EXPERIMENTAL

Provide maternal-infant skin-to-skin contact for preterm infants in the neonatal intensive care unit.

Behavioral: Skin-to-skin contact; Other: Routine care

Routine care group

OTHER

Perform routine nursing care for preterm infants in the neonatal intensive care unit.

Other: Routine care

Interventions

Skin-to-skin contact BEHAVIORAL

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.

Skin-to-skin contact group

Routine care OTHER

Preterm infants will receive standard nursing care provided by neonatal nurses in accordance with hospital principles during hospitalization.

Routine care group; Skin-to-skin contact group

Eligibility Criteria

• Age: 0 Hours - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Premature Birth; Fractures, Stress

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fractures, Bone; Wounds and Injuries

Study Officials

• Xiaojing Hu

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 16, 2022
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)