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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-06-30

Brief Summary

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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).

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Detailed Description

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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

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Preterm Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Skin-to-skin contact group

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

Group Type EXPERIMENTAL

Skin-to-skin contact

Intervention Type 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.

Routine care

Intervention Type OTHER

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

Routine care group

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

Group Type OTHER

Routine care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

Routine care

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

0 Hours

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No