N/A
N=10
Skin to Skin and Heart Rate Variability
Heart Rate Variability · Preterm Infant
Bottom Line
View on ClinicalTrials.gov: NCT05018910 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Heart Rate Variability — 9.68 ms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Skin to Skin (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate Variability |
9.68 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05018910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.