Neonatal Oxygen DesaturationNCT05968586
Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants
A study testing Body positioning in people with Neonatal Oxygen Desaturation and Premature, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the… Read more about this study
- Who is it for?
- Ages 1 minute to 3 months
- Conditions the study is for
- Neonatal Oxygen Desaturation, Premature, Ventilator Lung; Newborn
- What is being tested?
- Body positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 minute to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Viable infants born at ≤32 weeks of gestation on non-invasive NAVA.
- Infant must be stable on NAVA for at least 24 hours prior to the study
Who cannot join
- Infants with congenital heart disease (CHD)
- Infants with persistent pulmonary hypertension (PPHN)
- Infants with contraindications to using NAVA (e.g. neuromuscular blockage or paralysis, absent electrical signal from the diaphragm, esophageal tears or bleeding, cardiac pacemakers) or infants in whom an NG/OG catheter cannot be placed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Effect of Body Position on Oxygenation, Ventilation, and Diaphragmatic Workload in Premature Infants on Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA)
This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.
- Being tested
- Body positioning
- Keywords
- apnea of prematurity, NAVA
- Medical subject headings
- Asphyxia Neonatorum, Premature Birth, Bronchopulmonary Dysplasia, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body positioningOther
Body positioning of infants prone vs supine.
| Study group | Role | What they receive |
|---|---|---|
| Prone positioning | Experimental | Not described Receives: Other: Body positioning |
| Supine positioning | Active comparator | Not described Receives: Other: Body positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak electrical activity of the diaphragm (Edi peaks)
Height of Edi signal in uV
Measured: From enrollment in study to end of study (a total of twelve hours)
Minimum electrical activity of the diaphragm (Edi mins)
Lowest of Edi signal in uV
Measured: From enrollment in study to end of study (a total of twelve hours)
Number of apenic events
Number of times where infant ceases to breath for >5 seconds
Measured: From enrollment in study to end of study (a total of twelve hours)
Number of bradycardia events
Number of times where infant's heart rate drops <100bpm sustained for >5s
Measured: From enrollment in study to end of study (a total of twelve hours)
Number of desaturation events
Number of times where infant's oxygen saturation drops <85% sustained for >5s
Measured: From enrollment in study to end of study (a total of twelve hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start11 Sep 2023
- Primary completion28 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Oxygen DesaturationStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Darwish, Milton S. Hershey Medical Center
- Investigators
- Kristin Glass, MD, Study director, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968586
- Sponsor's protocol ID
- 22600
- Status last verified
- Jan 2025
- First submitted
- 21 Jul 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- 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 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Position on Oxygenation, Ventilation, and Diaphragmatic Workload in Premature Infants on Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA)
- ClinicalTrials.gov ID
- NCT05968586
- Acronym / sponsor ID
- 22600
- Keywords
- apnea of prematurity, NAVA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone positioning | Experimental | Other: Body positioning |
| Supine positioning | Active comparator | Other: Body positioning |
Who may qualify
- Ages
- 1 minute to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Viable infants born at ≤32 weeks of gestation on non-invasive NAVA.
- Infant must be stable on NAVA for at least 24 hours prior to the study
Key exclusion criteria (3 listed)
- Infants with congenital heart disease (CHD)
- Infants with persistent pulmonary hypertension (PPHN)
- Infants with contraindications to using NAVA (e.g. neuromuscular blockage or paralysis, absent electrical signal from the diaphragm, esophageal tears or bleeding, cardiac pacemakers) or infants in whom an NG/OG catheter cannot be placed.
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 |
|---|---|---|
| Body positioningBody positioning of infants prone vs supine. | Other | Prone positioning, Supine positioning |
Primary outcome
Peak electrical activity of the diaphragm (Edi peaks)
Time frame: From enrollment in study to end of study (a total of twelve hours)
Height of Edi signal in uV
Minimum electrical activity of the diaphragm (Edi mins)
Time frame: From enrollment in study to end of study (a total of twelve hours)
Lowest of Edi signal in uV
Number of apenic events
Time frame: From enrollment in study to end of study (a total of twelve hours)
Number of times where infant ceases to breath for >5 seconds
Number of bradycardia events
Time frame: From enrollment in study to end of study (a total of twelve hours)
Number of times where infant's heart rate drops <100bpm sustained for >5s
Number of desaturation events
Time frame: From enrollment in study to end of study (a total of twelve hours)
Number of times where infant's oxygen saturation drops <85% sustained for >5s
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Infant, Premature, Diseases, Premature Birth of Newborn
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Controlled Oxygen Desaturation Study of the Neonatal Wireless Transmission System
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Evaluation of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology and Eucapnic pH Assessment
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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.
Kristin Glass, MD study director
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body positioning in people with Neonatal Oxygen Desaturation and Premature, run by Milton S. Hershey Medical Center 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 2 inclusion and 3 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 29 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak electrical activity of the diaphragm (Edi peaks) (time frame: From enrollment in study to end of study (a total of twelve hours)). The study lists 5 primary outcomes in all. 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 29 Jan 2025.