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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin to Skin | Other | During routine Skin-to-skin sessions, the heart rate variability of the infant will be measured. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HRV Monitoring | All infants consented for the study had heart rate variability monitored before, during and after a skin-to-skin with the caregiver. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | ms | up to 2 hours duration |
|
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Duration of enrollment (1.5 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HRV Monitoring | All infants consented for the study had heart rate variability monitored before, during and after a skin-to-skin with the caregiver. There were not separate groups. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Maxwell, MD, MBA | University of New Mexico | 505-272-3967 | JRMaxwell@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2021 | Sep 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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All infants enrolled had their heart rate variability measured.
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| Participants |
|
| Age, Continuous | Median | Full Range | gestational age in weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Respiratory support during Heart rate variability (HRV) | Number | type of respiratory support |
|
| Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D000091642 | Urogenital Diseases |