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

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ClinicalTrials.gov Identifier: NCT02231801
Recruitment Status : Completed
First Posted : September 4, 2014
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Other Preterm Infants Behavioral: Mother-Infant Dyad

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vital Sign Monitoring of Mother-Infant Dyads During Kangaroo Care in Preterm Infants
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

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 Name: Kangaroo Care




Primary Outcome Measures :
  1. Heart Rate [ Time Frame: up to 30 minutes ]

Secondary Outcome Measures :
  1. Respiratory Rate [ Time Frame: up to 30 minutes ]
  2. Oxygen Saturation [ Time Frame: up to 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231801


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Ian Holzman, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02231801     History of Changes
Other Study ID Numbers: GCO 14-1323
PD14-03941
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by Icahn School of Medicine at Mount Sinai:
Preterm
Kangaroo Care
Skin-to-Skin
Vital Sign
Heart Rate
Respiratory Rate
Oxygen Saturation

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications