Evaluating the Effects of Kangaroo Care in the NICU

NCT04727125 | Completed

• 1 other identifier: 2019-2539
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

The main hypothesis of this study is that Kangaroo Father Care (KFC) will positively impact acute physiologic and long-term behavioral outcomes in infants, fathers, and families.

Conditions

Kangaroo Care; Premature Birth; Fathers

Outcome Measures

Primary Outcomes (2)

• Infant Cardiorespiratory Stability

  Heart rate (HR), oxygen saturation (SpO2), and HR variability (HRV) data collected before, during, and after KC will be combined to report infant cardiorespiratory stability.

  up to 48 hours, during scheduled skin-to-skin participation

• Parent Physiologic Stress

  Parent physiologic stress will be assessed through heart rate (HR) and HR variability (HRV) data collected before, during, and after KC.

  up to 48 hours, during scheduled skin-to-skin participation

Secondary Outcomes (7)

• Accelerometry Accuracy

  up to 48 hours, during scheduled skin-to-skin participation

• Infant Salivary Biomarker Analysis

  Up to 4 hours. Before, during, and after each study skin-to-skin session

• Parent Stress Response

  Up to 4 hours. Before, during, and after each study skin-to-skin session

• Paternal Bonding

  Up to 4 hours. Before, during, and after each study skin-to-skin session

• Parent Sense of Competency

  An average of 4 weeks. Day before discharge, 2 weeks post discharge, 4 weeks post discharge

Eligibility Criteria

• Age: 1 Day - 20 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates (birth to less than 1 month) and adults (18 years and older)

You may not qualify if:

• Infants: Infants who are intubated or sedated, are receiving vasopressors or analgesics, have any congenital anomalies or skin abnormalities deemed likely to impact KC by clinical team, have received or are planned to receive surgical intervention, or are experiencing other symptoms or receiving other intervention that will impact the utilization of KC, wearable sensors, and/or oral swabs will be excluded from this study.
• Parents: Parents who are showing any signs of illness or taking corticosteroids or testosterone supplementation will be excluded from this study. Non-English speaking parents will also be excluded from this study because the questionnaires associated with this study are only available in English.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Northwestern University: collaborator

Study Sites (2)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva is collected from infants, mothers, and fathers

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Craig F Garfield, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Medical Social Sciences

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 27, 2021
• Study Start: May 17, 2019
• Primary Completion: April 12, 2021
• Study Completion: January 1, 2022
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

US (2)