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Clinical Trials/NCT02231801
NCT02231801
Completed
N/A

Vital Sign Monitoring of Mother-Infant Dyads During Kangaroo Care in Preterm Infants

Icahn School of Medicine at Mount Sinai1 site in 1 country40 target enrollmentSeptember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Other Preterm Infants
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
40
Locations
1
Primary Endpoint
Heart Rate
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
September 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Heart Rate

Time Frame: up to 30 minutes

Secondary Outcomes

  • Respiratory Rate(up to 30 minutes)
  • Oxygen Saturation(up to 30 minutes)

Study Sites (1)

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