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

NCT02231801 | Completed

• 2 other identifiers: GCO 14-1323PD14-03941
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Preterm Infants

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Heart Rate

  up to 30 minutes

Secondary Outcomes (2)

• Respiratory Rate

  up to 30 minutes

• Oxygen Saturation

  up to 30 minutes

Study Arms (1)

Mother-Infant Dyad

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

Behavioral: Mother-Infant Dyad

Interventions

Mother-Infant Dyad BEHAVIORAL

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

Also known as: Kangaroo Care

Mother-Infant Dyad

Eligibility Criteria

• Age: 30 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• outborn infants
• gestational age less that 29 6/7 weeks or greater than 35 0/7 weeks
• any major congenital anomalies
• sepsis and/or any other serious clinical complication precluding kangaroo care

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ian Holzman, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 4, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

US (1)