Heart Rate VariabilityNCT05018910
Skin to Skin and Heart Rate Variability
A study testing Skin to Skin in people with Heart Rate Variability and Preterm Infant, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 6 weeks
- Conditions the study is for
- Heart Rate Variability, Preterm Infant
- What is being tested?
- Skin to Skin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jul 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: Investigating the Impact of Skin to Skin on Preterm Infant Heart Rate Variability
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.
Read the detailed description
This will be a prospective crossover study, with each infant serving as their own control. Any infant for whom the parent has consented to participate in the study will have heart rate variability leads applied and be monitored before, during and after a skin-to-skin session with the infant's parent. Due to the nature of the study, blinding is not feasible. Infants will remain on the hospital cardiac monitor during the study to maintain standard of care, and data obtained in this study will not be used for clinical care. All sessions will occur during the infant's NICU admission.
Infants will be screened for eligibility by reviewing the Newborn Intensive Care Unit (NICU) census daily. Consent will be obtained after an infant has delivered. No pregnant women will be approached for consent.
Any infant who has been consented for participation and completes at least 1 skin to skin session will be included in the final study sample. As skin to skin is part of standard of care, and information, aside from gender, will not be obtained from the parent, consent will be obtained for the infant to participate in the study.
This study is observational because there was no randomization (no intervention).
- Conditions
- Heart Rate Variability, Preterm Infant
- Being tested
- Skin to Skin
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin to SkinOther
During routine Skin-to-skin sessions, the heart rate variability of the infant will be measured.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Skin to Skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 hours duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start4 Jul 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessie R. Maxwell, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018910
- Sponsor's protocol ID
- ID: 21-177
- Status last verified
- Sep 2024
- First submitted
- 17 Aug 2021
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Skin to Skin on Preterm Infant Heart Rate Variability
- ClinicalTrials.gov ID
- NCT05018910
- Acronym / sponsor ID
- ID: 21-177
- Conditions
- Heart Rate Variability, Preterm Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 4 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a prospective crossover study, with each infant serving as their own control. Any infant for whom the parent has consented to participate in the study will have heart rate variability leads applied and be monitored before, during and after a skin-to-skin session with the infant's parent. Due to the nature of the study, blinding is not feasible. Infants will remain on the hospital cardiac monitor during the study to maintain standard of care, and data obtained in this study will not be used for clinical care. All sessions will occur during the infant's NICU admission.
Infants will be screened for eligibility by reviewing the Newborn Intensive Care Unit (NICU) census daily. Consent will be obtained after an infant has delivered. No pregnant women will be approached for consent.
Any infant who has been consented for participation and completes at least 1 skin to skin session will be included in the final study sample. As skin to skin is part of standard of care, and information, aside from gender, will not be obtained from the parent, consent will be obtained for the infant to participate in the study.
This study is observational because there was no randomization (no intervention).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Heart Rate Variability | Other | Other: Skin to SkinAll 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. |
Who may qualify
- Ages
- 1 day to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin to SkinDuring routine Skin-to-skin sessions, the heart rate variability of the infant will be measured. | Other | Heart Rate Variability |
Primary outcome
Heart Rate Variability
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin to Skin in people with Heart Rate Variability and Preterm Infant, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: up to 2 hours duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.