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Completed

NCT Number: NCT02231801

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

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.

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Key information

Conditions

Other Preterm Infants Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

30 week–35 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mother-Infant Dyad

Behavioral

Skin-to-skin holding of preterm infants by their mothers

Other names: Kangaroo Care

Primary outcomes

  1. Heart Rate

    Time frame: up to 30 minutes

Secondary outcomes

  1. Respiratory Rate

    Time frame: up to 30 minutes

  2. Oxygen Saturation

    Time frame: up to 30 minutes

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2014
Registry last updated
Dec 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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