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
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Changes on the concentration of cortisol of preterm infants
Overview
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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 0 Hours to 24 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Changes on the concentration of cortisol of preterm infants
Time Frame: From 3 days of life (baseline) to 7 days of life
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.
Secondary Outcomes
- Crying time(At the preterm infants 7 days of life)
- Length of hospital stays(Through study completion, an average of 40 days)
- 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)