Mild Respiratory DistressEarly Phase 1NCT07390812
Respiratory Transition Without Continuous Positive Airway Pressure
A Early Phase 1 study testing Transition without Continuous Positive Airway Pressure (CPAP) and CPAP in people with Mild Respiratory Distress, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
The primary aim of this research project is to determine if term neonates (37:0 to 41:6 weeks' gestational age) with mild respiratory distress can safely transition without continuous positive airway pressure (CPAP). Read more about this study
- Who is it for?
- Ages 37 to 41 weeks
- Conditions the study is for
- Mild Respiratory Distress
- What is being tested?
- Transition without Continuous Positive Airway Pressure (CPAP) and CPAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 37 to 41 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Full term infants (37 weeks + 0days to 41 weeks +6days gestational age)
- Born via scheduled c-sections without labor
- Who develop mild respiratory distress, defined as nasal flaring or, intermittent grunting, and/or mild retractions and/or +/- mild tachypnea ( respiratory rate 61-90).
Who cannot join
- Moderate to severe respiratory distress (continuous grunting, or moderate retractions or respiratory rate greater than 90 breaths per minute),
- need for positive pressure ventilation (PPV) or advanced resuscitation in the first 5 minutes of life,
- meconium stained amniotic fluid,
- major congenital anomalies or chromosomal abnormalities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack Univeristy Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Respiratory Transition Without Continuous Positive Airway Pressure in Term Infants With Mild Respiratory Distress: A Pilot Study
The primary aim of this research project is to determine if term neonates (37:0 to 41:6 weeks' gestational age) with mild respiratory distress can safely transition without continuous positive airway pressure (CPAP). The secondary aim is to determine the incidence of pneumothorax (PTX) for all term neonates assessed to have mild respiratory distress in the delivery room (DR).
- Conditions
- Mild Respiratory Distress
- Being tested
- Transition without Continuous Positive Airway Pressure (CPAP), CPAP
- Keywords
- mild respiratory distress, term neonates, continuous positive airway pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition without Continuous Positive Airway Pressure (CPAP)Other
Allowing transition without CPAP administration was assessed at 25 minutes of life
CPAPOther
CPAP administration as per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Continuous positive airway pressure (CPAP) is administered for mild respiratory distress Receives: Other: CPAP |
| Watchful waiting | Experimental | Neonates with mild respiratory distress are observed for 20 minutes, and CPAP is administered at 25 minutes of life if respiratory distress continues or earlier if moderate to severe respiratory distress occurs Receives: Other: Transition without Continuous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for CPAP use at 25 minutes of life
Babies with mild respiratory distress will be observed for 20 minutes (randomized at 5 minutes of life) using a pulse oximeter (per institutional post-resuscitation care guidelines) and under the study team's direct observation.
The active cohort will not receive CPAP unless respiratory distress worsens.
Measured: At 25 minutes post birth (after 20 minutes of observation)
Secondary outcomes (2)
Prevalence of pneumothorax in neonates
Number of babies with pneumothorax in neonates as assessed by a chest ultrasound.
Measured: Within 6 hours of life
NICU (Neonatal Intensive Care Unit) admission during hospital stay
Number of babies admitted to the NICU for respiratory distress during the initial hospital stay (on average, 1-4 days).
Measured: Hospital day (from birth to discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start11 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Respiratory DistressStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Spillane, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390812
- Sponsor's protocol ID
- Pro2022-0654
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Transition Without Continuous Positive Airway Pressure in Term Infants With Mild Respiratory Distress: A Pilot Study
- ClinicalTrials.gov ID
- NCT07390812
- Acronym / sponsor ID
- Pro2022-0654
- Conditions
- Mild Respiratory Distress
- Keywords
- mild respiratory distress, term neonates, continuous positive airway pressure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Feb 2026 (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.
The primary aim of this research project is to determine if term neonates (37:0 to 41:6 weeks' gestational age) with mild respiratory distress can safely transition without continuous positive airway pressure (CPAP). The secondary aim is to determine the incidence of pneumothorax (PTX) for all term neonates assessed to have mild respiratory distress in the delivery room (DR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: CPAPContinuous positive airway pressure (CPAP) is administered for mild respiratory distress |
| Watchful waiting | Experimental | Other: Transition without Continuous Positive Airway Pressure (CPAP)Neonates with mild respiratory distress are observed for 20 minutes, and CPAP is administered at 25 minutes of life if respiratory distress continues or earlier if moderate to severe respiratory distress occurs |
Who may qualify
- Ages
- 37 to 41 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Full term infants (37 weeks + 0days to 41 weeks +6days gestational age)
- Born via scheduled c-sections without labor
- Who develop mild respiratory distress, defined as nasal flaring or, intermittent grunting, and/or mild retractions and/or +/- mild tachypnea ( respiratory rate 61-90).
Key exclusion criteria (4 listed)
- Moderate to severe respiratory distress (continuous grunting, or moderate retractions or respiratory rate greater than 90 breaths per minute),
- need for positive pressure ventilation (PPV) or advanced resuscitation in the first 5 minutes of life,
- meconium stained amniotic fluid,
- major congenital anomalies or chromosomal abnormalities.
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 |
|---|---|---|
| Transition without Continuous Positive Airway Pressure (CPAP)Allowing transition without CPAP administration was assessed at 25 minutes of life | Other | Watchful waiting |
| CPAPCPAP administration as per standard of care | Other | Standard of care |
Primary outcome
Need for CPAP use at 25 minutes of life
Time frame: At 25 minutes post birth (after 20 minutes of observation)
Babies with mild respiratory distress will be observed for 20 minutes (randomized at 5 minutes of life) using a pulse oximeter (per institutional post-resuscitation care guidelines) and under the study team's direct observation. The active cohort will not receive CPAP unless respiratory distress worsens.
2 secondary outcomes
Prevalence of pneumothorax in neonates
Time frame: Within 6 hours of life
NICU (Neonatal Intensive Care Unit) admission during hospital stay
Time frame: Hospital day (from birth to discharge)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- 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.
Nicole Spillane, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Transition without Continuous Positive Airway Pressure (CPAP) and CPAP in people with Mild Respiratory Distress, run by Hackensack Meridian Health 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Need for CPAP use at 25 minutes of life (time frame: At 25 minutes post birth (after 20 minutes of observation)). 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 27 Feb 2026.