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

Study Overview
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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).

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.

Official Title
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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

Conditions
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Preterm Infant

Intervention / Treatment
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* Behavioral: Skin-to-skin contact
* Other: Routine care


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Hours
Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin-to-skin contact group<br>Provide maternal-infant skin-to-skin contact for preterm infants in the neonatal intensive care unit. | Behavioral: Skin-to-skin contact<br>* 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.<br>Other: Routine care<br>* Preterm infants will receive standard nursing care provided by neonatal nurses in accordance with hospital principles during hospitalization.<br>|
| Other: Routine care group<br>Perform routine nursing care for preterm infants in the neonatal intensive care unit. | Other: Routine care<br>* Preterm infants will receive standard nursing care provided by neonatal nurses in accordance with hospital principles during hospitalization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress response, Skin-to-skin contact, Cortisol