Trial Outcomes & Findings for Skin to Skin and Heart Rate Variability (NCT NCT05018910)

NCT ID: NCT05018910

Last Updated: 2024-11-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: up to 2 hours duration
• Results posted on: 2024-11-21

Participant Flow

Participant milestones

Measure	HRV Monitoring All infants consented for the study had heart rate variability monitored before, during and after a skin-to-skin with the caregiver. All infants had the heart rate variability completed; infants were not treated differently. If an infant was consented for the study, the heart rate variability was recorded during an already planned skin-to-skin session with the caregiver. The "before period" of the skin-to-skin session was NO skin-to-skin heart rate variability (pre); during skin to skin was heart rate variability during the session; the after period of the skin-to-skin session was NO skin-to-skin heart rate variability (post) but obtained after the session.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Skin to Skin and Heart Rate Variability

Baseline characteristics by cohort

Measure	HRV Monitoring n=10 Participants All infants consented for the study had heart rate variability monitored before, during and after a skin-to-skin with the caregiver.
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29 gestational age in weeks n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Respiratory support during Heart rate variability (HRV) Continuous positive pressure	7 type of respiratory support n=5 Participants
Respiratory support during Heart rate variability (HRV) Nasal canula	3 type of respiratory support n=5 Participants

PRIMARY outcome

Timeframe: up to 2 hours duration

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.

Outcome measures

Measure	HRV Monitoring n=10 Participants All infants consented for the study had heart rate variability monitored before, during and after a skin-to-skin with the caregiver. The outcome measure provided is the Standard Deviation of the normal-to-normal interval (SDNN) obtained after the session was completed.
Heart Rate Variability	9.68 ms Interval 1.45 to 17.91

Adverse Events

HRV Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessie Maxwell, MD, MBA

University of New Mexico

Phone: 505-272-3967

Email: JRMaxwell@salud.unm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place