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

NCT ID: NCT02231801

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Other Preterm Infants

Keywords

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Preterm Kangaroo Care Skin-to-Skin Vital Sign Heart Rate Respiratory Rate Oxygen Saturation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mother-Infant Dyad

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

Mother-Infant Dyad

Intervention Type BEHAVIORAL

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

Interventions

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Mother-Infant Dyad

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Kangaroo Care

Eligibility Criteria

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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

* any major congenital anomalies
* sepsis and/or any other serious clinical complication precluding kangaroo care

Exclusion Criteria

* outborn infants
* gestational age less that 29 6/7 weeks or greater than 35 0/7 weeks
Minimum Eligible Age

30 Weeks

Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian Holzman, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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PD14-03941

Identifier Type: -

Identifier Source: secondary_id

GCO 14-1323

Identifier Type: -

Identifier Source: org_study_id