Monitoring of Vital Signs During Skin-to-skin Holding by Mothers of Their Preterm Babies

Completed

• Conditions: Other Preterm Infants
• Interventions: Behavioral: Mother-Infant Dyad

• Registration Number: NCT02231801
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

This observational study aims to monitor the vital sign changes in both mother and baby that occur during kangaroo care in preterm infants and to investigate any potential correlations between maternal measurement values and those of the infant. The purpose of this observational study is to look for a method to track the earliest responses that could, theoretically, be considered as 'social responses' in hopes of providing developmental interventions earlier to at-risk infants.

Detailed Description

The goal of this observational study is to identify any signs of early "social response" in order to be able to assist infants that lack this response with early neurobehavioral modifications.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2015-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• inborn at Mount Sinai
• gestational age between 30 0/7 weeks and 34 6/7 weeks gestation
• only one infant of a multiple gestation
• plan by family to do kangaroo care during NICU stay

Exclusion Criteria

• outborn infants
• gestational age less that 29 6/7 weeks or greater than 35 0/7 weeks
• other infants of multiple gestation (see inclusion criteria)
• any major congenital anomalies
• sepsis and/or any other serious clinical complication precluding kangaroo care

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mother-Infant Dyad	Mother-Infant Dyad	Skin-to-skin holding of preterm infants by their mothers

Primary Outcome Measures

Name	Time	Method
Heart Rate	up to 30 minutes

Secondary Outcome Measures

Name	Time	Method
Respiratory Rate	up to 30 minutes
Oxygen Saturation	up to 30 minutes

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States