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

Other Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231801
• Other study ID #: GCO 14-1323
• Secondary ID: PD14-03941
• Status: Completed
• Phase: N/A
• First received: September 2, 2014
• Last updated: December 29, 2015
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Weeks to 35 Weeks

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Other Preterm Infants
• Premature Birth

Intervention

Behavioral:
• Mother-Infant Dyad
Skin-to-skin holding of preterm infants by their mothers

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate		up to 30 minutes	No
Secondary	Respiratory Rate		up to 30 minutes	No
Secondary	Oxygen Saturation		up to 30 minutes	No