Skin to Skin and Heart Rate Variability

NCT05018910 | Completed Results

• 1 other identifier: ID: 21-177
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to monitor heart rate variability in preterm infants receiving respiratory support, including conventional mechanical ventilation, during skin-to-skin care. We hypothesize that skin to skin care will be associated with a more mature pattern of parasympathetic activity as measured by various domains of heart rate variability. Specifically, the standard deviation of the normal-to-normal interval (SDNN), the root mean squared of successive differences of normal-to-normal intervals (RMSDD), and the standard deviation of deceleration (SDDec) will decrease in infants that are receiving skin-to-skin care across all types of respiratory support compared to infants who are lying in their isolette.

Conditions

Heart Rate Variability; Preterm Infant

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  The standard deviation of the normal-to-normal interval, the root mean squared of successive differences of normal-to-normal intervals and the standard deviation of deceleration will be measured before, during and after a skin to skin sessions.

  up to 2 hours duration

Study Arms (1)

Heart Rate Variability

OTHER

All infants enrolled in the study had their heart rate variability measured before, during, and after skin-to-skin sessions. This was the only arm of the study.

Other: Skin to Skin

Interventions

Skin to Skin OTHER

During routine Skin-to-skin sessions, the heart rate variability of the infant will be measured.

Heart Rate Variability

Eligibility Criteria

• Age: 1 Day - 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants must be less than or equal to 30 weeks gestational age at time of delivery.
• Both inborn and outborn infants are eligible for this study.
• Infants must be less than 6 weeks postnatal age.
• Infants must have had a cranial ultrasound with results showing no intraventricular severe intraventricular hemorrhage (Grade III or IV) \[10\].
• Infants must require respiratory support at the time of the first session. This will include mechanical ventilation, noninvasive positive pressure ventilation (NIPPV), continuous positive airway pressure (CPAP), high flow nasal cannula (HFNC) or low flow nasal cannula (LFNC).
• Consenting biological or legal adoptive mother of the infant must speak English. If the study is unable to enroll an appropriate number of patients, will consider including non-English speaking patients. However, due to limited resources for this study, we will start with only English-speaking patients. Biological or legal adoptive mother will provide consent for the infant to participate in this study.
• Biological or legal adoptive fathers of the infant are eligible to complete skin to skin sessions with the infant. As we are not collecting any information from the father, and skin to skin is a part of accepted standard of care, consent will not be obtained from the father.
• Infants of employees are eligible to participate. Undue influence or coercion will not be applied to infants of employees and participation or lack thereof will not affect employment status.

You may not qualify if:

• Infants who have not received a head ultrasound.
• Infants with grade III or higher intraventricular hemorrhage identified on a head ultrasound.
• Infants on high frequency ventilation, due to the artifact transmitted to ECG.
• Infants with known genetic disorders or known prenatal chromosomal anomalies.
• Infants with one or more major congenital anomaly.
• Infants undergoing active sepsis evaluation or treatment for infection.
• Infants on blood pressure or cardiac medications or infusions including inotropic mediations.
• Mothers (biological or legal adoptive) that are \<18 years of age will not be approached for consent.
• Mothers (biological or legal adoptive) who are unable to provide consent due to having a legal representative will not be approached for consent in this study.
• Mothers (biological or legal adoptive) who are prisoners will not be approached for this study as participation requires multiple skin to skin session with the infant

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jessie Maxwell, MD, MBA
• Organization: University of New Mexico

JRMaxwell@salud.unm.edu

505-272-3967

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All infants enrolled had their heart rate variability measured.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Neurosciences

Model Details: All infants enrolled in the study had their heart rate variability measured before, during, and after skin-to-skin sessions. There was no randomization or testing of efficacy.

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: July 4, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)