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

Preterm Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05503238
• Other study ID #: 2022 -31
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Children's Hospital of Fudan University
• Contact: Wenjuan Han, Master
• Phone: +8613020123256
• Email: hanxi1128[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 24 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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