Respiratory DistressNCT01310153
Effect of Supine or Prone Position After Caesarean Birth
A study testing prone positioning and Supine in people with Respiratory Distress and Transient Tachypnea of the Newborn, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective Caesarean birth. There has been no study comparing the efficacy of immediately positioning a newly born infant prone vs. supine for the first 30 60 seconds of life after delivery by Caesarean birth. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress, Transient Tachypnea of the Newborn, Delayed Transition of the Newborn
- What is being tested?
- prone positioning and Supine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 2009
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any woman not in labor who are undergoing elective Cesarean birth at term, 37 to 41 completed weeks gestation.
Who cannot join
- any woman with prior rupture of membranes
- diabetes mellitus, gestational diabetes,
- any woman receiving sedation
- using medication such as Demerol, magnesium sulfate or general anesthesia
- any woman who has a known drug history
- any known macrosomia
Show all 11Show fewer
- known congenital anomalies or meconium stained fluid
- any woman with illnesses such as maternal fever, chorioamnionitis, severe neonatal distress
- any woman with compromised infant at delivery
- oligohydramnios
- history of antenatal steroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jack D. Weiler Hospital of the Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective Caesarean Birth
Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective Caesarean birth. There has been no study comparing the efficacy of immediately positioning a newly born infant prone vs. supine for the first 30 60 seconds of life after delivery by Caesarean birth.
Read the detailed description
This study hypothesizes that when the infant is prone they will have postural drainage, better dorsal lung expansion, less vagal response from suctioning and less agitation secondary to the righting reflex.
This study will compare 1033 term babies divided by randomization into two groups prone and supine. During the study, care givers will monitor and record incidence and severity of Respiratory Distress, Use of FiO2 or respiratory support, admissions to NICU.
- Conditions
- Respiratory Distress, Transient Tachypnea of the Newborn, Delayed Transition of the Newborn, Persistent Pulmonary Hypertension
- Being tested
- prone positioning, Supine
- Medical subject headings
- Dyspnea, Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positioningProcedure or surgery
newborn babies in prone positioning
SupineProcedure or surgery
newborn babies in supine positioning
| Study group | Role | What they receive |
|---|---|---|
| Prone Positioning | Active comparator | Newly born infant placed in prone position (face up) for the first 30 60 seconds of life after delivery by Cesarean birth. Receives: Procedure: prone positioning |
| Supine Positioning | Active comparator | newly born infant placed in supine position (face down) for the first 30 60 seconds of life after delivery by Cesarean birth. Receives: Procedure: Supine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startSep 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DistressStudies of the same condition, open and under way.
- More trials run by Montefiore 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orna Rosen, Montefiore Medical Center
- Investigators
- Orna Rosen, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310153
- Sponsor's protocol ID
- 06-09-409
- Status last verified
- Aug 2018
- First submitted
- 4 Mar 2011
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective Caesarean Birth
- ClinicalTrials.gov ID
- NCT01310153
- Acronym / sponsor ID
- 06-09-409
- Conditions
- Respiratory Distress, Transient Tachypnea of the Newborn, Delayed Transition of the Newborn, Persistent Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Mar 2011 (estimated)
- 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.
Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective Caesarean birth. There has been no study comparing the efficacy of immediately positioning a newly born infant prone vs. supine for the first 30 60 seconds of life after delivery by Caesarean birth.
Detailed description
This study hypothesizes that when the infant is prone they will have postural drainage, better dorsal lung expansion, less vagal response from suctioning and less agitation secondary to the righting reflex.
This study will compare 1033 term babies divided by randomization into two groups prone and supine. During the study, care givers will monitor and record incidence and severity of Respiratory Distress, Use of FiO2 or respiratory support, admissions to NICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone Positioning | Active comparator | Procedure: prone positioningNewly born infant placed in prone position (face up) for the first 30 60 seconds of life after delivery by Cesarean birth. |
| Supine Positioning | Active comparator | Procedure: Supinenewly born infant placed in supine position (face down) for the first 30 60 seconds of life after delivery by Cesarean birth. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any woman not in labor who are undergoing elective Cesarean birth at term, 37 to 41 completed weeks gestation.
Key exclusion criteria (11 listed)
- any woman with prior rupture of membranes
- diabetes mellitus, gestational diabetes,
- any woman receiving sedation
- using medication such as Demerol, magnesium sulfate or general anesthesia
- any woman who has a known drug history
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 |
|---|---|---|
| prone positioningnewborn babies in prone positioning | Procedure or surgery | Prone Positioning |
| Supinenewborn babies in supine positioning | Procedure or surgery | Supine Positioning |
Primary outcome
Not reported in the source record.
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 31 Aug 2018.
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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.
Orna Rosen, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prone positioning and Supine in people with Respiratory Distress and Transient Tachypnea of the Newborn, run by Montefiore 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 1 inclusion and 11 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 31 Aug 2018. 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.
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 31 Aug 2018.