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

December 29, 2015 updated by: Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants born at Mt. Sinai Hospital and admitted to the NICU. Preterm infants between 30 0/7 weeks gestational age to 34 6/7 weeks gestation age.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mother-Infant Dyad
Skin-to-skin holding of preterm infants by their mothers
Behavioral: Mother-Infant Dyad
Skin-to-skin holding of preterm infants by their mothers
Other Names:
  • Kangaroo Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Heart Rate
Time Frame: up to 30 minutes
up to 30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Respiratory Rate
Time Frame: up to 30 minutes
up to 30 minutes
Oxygen Saturation
Time Frame: up to 30 minutes
up to 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Ian Holzman, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 14-1323
  • PD14-03941

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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