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

Fudan University

Status: Withdrawn

Conditions: Preterm Infant

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05503238

2022 -31

Details and patient eligibility

About

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 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.

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Skin-to-skin contact group

Experimental group

Description:

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

Treatment:

Other: Routine care

Behavioral: Skin-to-skin contact

Routine care group

Other group

Description:

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

Treatment:

Other: Routine care