Prone vs Supine Effects on Respiratory OutcomesNCT02692573
Prone or Supine Effect After Caesarean Delivery on Respiratory Outcomes in Full Term Infants
A study testing positioning in people with Prone vs Supine Effects on Respiratory Outcomes, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Investigators will compare 500 full term babies delivered by SCD randomized into two groups, prone or supine position. Investigators will use a Panda warmer with built in Nellcor pulse oximeter. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prone vs Supine Effects on Respiratory Outcomes
- What is being tested?
- positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 18 Dec 2018
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Obstetrical patients delivering at Weiler Hospital.
- Any woman not in labor, who is undergoing scheduled caesarean deliveries at term (37 - 42 completed weeks of gestation),
Who cannot join
- Women with prior rupture of membranes
- Women receiving magnesium sulfate
- Women with known illegal drug history
- fetus with known congenital anomalies or if meconium stained fluid is present.
- mother with maternal fever, chorioamnionitis
- babies experiencing fetal distress e.g. abnormal fetal heart tracing,
- non vigorous newborn at birth (defined as per NRP guidelines as infant with apnea/gasping, heart rate <100/min, poor tone).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prone or Supine Effect of Immediate Positioning After Scheduled Caesarean Delivery on Respiratory Outcomes in Full Term Infants
Investigators will compare 500 full term babies delivered by SCD randomized into two groups, prone or supine position. Investigators will use a Panda warmer with built in Nellcor pulse oximeter. Each infant will have heart rate (HR), oxygen saturation via pulse oximetry, respiratory rate and respiratory effort documented every 1 minute for the first 5 minutes of life; beyond the initial 5minutes of life, monitoring as well as infant's management will be done as per current Weiler hospital protocols. The intervention group will be placed in prone position for first five minutes immediately after birth, and then changed to supine position. The control group will be placed supine from birth. Investigators will check for the incidence and severity of RD, supplemental oxygen need and duration, positive pressure ventilation (PPV) need and duration or other use of respiratory support (intubation). Additionally, investigators will record the number of infants requiring admission to the NICU in each group, days of ventilatory support as well as the length of hospitalization.
Read the detailed description
- Consent obtained prior to actual operative delivery and anesthesia
- Prior to start of surgery an opaque envelope with random selection of post delivery position, supine or prone, is opened
- Pediatric team confirms with Obstetrician and delivery team the position in which the infant will be given to pediatrics
- Pediatric team member accepting the infant stays by the operating room table to observe the delivery At actual delivery, the Panda radiant warmer Apgar clock will be started by a Pediatric team member positioned at the warmer when the baby is delivered. Vitals signs of HR, color and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be noted. The Apgar clock is available to document the timing of the minute intervals heart rate and oxygen saturations on the preprinted grid of the survey data sheet.
- When a Group A (supine) infant's transfer is made to Pediatrics, the infant will be kept in the supine position in transit to warmer and on warmer until first towel drying completed, 30 - 60 seconds, consistent with NRP protocol. Pulse oximetry and temperature probe will be placed. Vitals signs of HR, color and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be noted.
When a Group B (start in prone position) the obstetrician places the baby in prone position, clamps and cuts cord. The baby is given to Pediatrics in the prone position. The infant will be kept in the prone position in transit to warmer and on warmer for first towel drying completed. Pulse oximetry and temperature probe will be placed. Vitals signs of HR, RR and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be documented.
- As toweling is changed the baby in prone position continues as such until five minutes pass. After five minutes the baby is turned to supine position as per standard NRP protocol.
- Decision to initiate positive pressure ventilation and /or oxygen supplementation will be guided by published NRP 2010 lower saturation targets (1 min <60%, 2 min <65%, 3 min <70%, 4 min <75%, 5 min <80%) and/or by grunting, retractions ; discontinuation by high saturation targets (1min >65%, 2 min >70%, 3min >>75%, 4 min >80%, 5 min >85%) and resolution of respiratory distress. Positive pressure ventilation will be delivered via Neopuff device in supine position (both groups); CPAP 5cm 21% initially, then the amount of oxygen will be titrated to meet oxygen saturation target for given minute of life.
- After no more than 30 minutes, Primary Assignment for admission to the NBN vs. NICU is made by a trained member of the study who was not in the operating room at the beginning of the delivery when the initial positioning of the infant was revealed. This is possible with 24 hour coverage from attendings, fellows, and mid-level practioners. Determination is based on Weiler NICU admission protocols.
- If infant is to go to NBN then STS and breastfeeding protocols will be followed.
- Infants developing respiratory distress in the NBN will be transferred to the NICU for further evaluation and care 12. Infants admitted to NICU directly or via NBN would have vital signs monitored as per NICU nursing protocol until discharge 13. Documentation of Length of Stay in NBN or NICU will collected 14. Documentation of intensity of care, type of support, maximum FiO2 required and duration of respiratory support in NICU will be collected.
- Being tested
- positioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positioningOther
prone positioning for the initial 5 minutes of life
positioningOther
supine positioning for the initial 5 minutes of life
| Study group | Role | What they receive |
|---|---|---|
| prone | Experimental | Prone positioned after delivery Receives: Other: positioning |
| supine | Active comparator | Supine positioned after delivery Receives: Other: positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administration of positive pressure ventilation and/or oxygen in prone vs supine groups
any administration of positive pressure ventilation and /or oxygen
Measured: 30 minutes
Secondary outcomes (4)
Differences in pulse oximetry recordings between prone and supine groups
Investigators will record saturations in % at 1 min, 2 min, 3 min, 4 min, 5 min intervals and compare between the groups.
Measured: 5 minutes
Differences in heart rate between prone and supine groups
Investigators will record heart rate (beats/minute) at 1 min, 2 min, 3 min, 4 min, 5 min time points
Measured: 5 minutes
Differences in respiratory rate between prone and supine groups
Investigators will record respiratory rate (beats/minute) at 1 min, 2 min, 3 min, 4 min, 5 min time points
Measured: 5 minutes
Differences in neonatal intensive care admission rates between prone and supine groups
Neonatal resuscitation team leader makes the decision regarding neonatal intensive care admission need as per Weiler Hospital/Montefiore guidelines; rates will be compared between the two groups.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startDec 2015
- Primary completion2 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prone vs Supine Effects on Respiratory OutcomesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Havranek, Montefiore Medical Center
- Investigators
- Thomas Havranek, MD, Principal investigator, Albert Einstein University/Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692573
- Sponsor's protocol ID
- 2015-5470
- Status last verified
- Feb 2019
- First submitted
- 16 Feb 2016
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone or Supine Effect of Immediate Positioning After Scheduled Caesarean Delivery on Respiratory Outcomes in Full Term Infants
- ClinicalTrials.gov ID
- NCT02692573
- Acronym / sponsor ID
- 2015-5470
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 26 Feb 2016 (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.
Investigators will compare 500 full term babies delivered by SCD randomized into two groups, prone or supine position. Investigators will use a Panda warmer with built in Nellcor pulse oximeter. Each infant will have heart rate (HR), oxygen saturation via pulse oximetry, respiratory rate and respiratory effort documented every 1 minute for the first 5 minutes of life; beyond the initial 5minutes of life, monitoring as well as infant's management will be done as per current Weiler hospital protocols. The intervention group will be placed in prone position for first five minutes immediately after birth, and then changed to supine position. The control group will be placed supine from birth. Investigators will check for the incidence and severity of RD, supplemental oxygen need and duration, positive pressure ventilation (PPV) need and duration or other use of respiratory support (intubation). Additionally, investigators will record the number of infants requiring admission to the NICU in each group, days of ventilatory support as well as the length of hospitalization.
Detailed description
- Consent obtained prior to actual operative delivery and anesthesia
- Prior to start of surgery an opaque envelope with random selection of post delivery position, supine or prone, is opened
- Pediatric team confirms with Obstetrician and delivery team the position in which the infant will be given to pediatrics
- Pediatric team member accepting the infant stays by the operating room table to observe the delivery At actual delivery, the Panda radiant warmer Apgar clock will be started by a Pediatric team member positioned at the warmer when the baby is delivered. Vitals signs of HR, color and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be noted. The Apgar clock is available to document the timing of the minute intervals heart rate and oxygen saturations on the preprinted grid of the survey data sheet.
- When a Group A (supine) infant's transfer is made to Pediatrics, the infant will be kept in the supine position in transit to warmer and on warmer until first towel drying completed, 30 - 60 seconds, consistent with NRP protocol. Pulse oximetry and temperature probe will be placed. Vitals signs of HR, color and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be noted.
When a Group B (start in prone position) the obstetrician places the baby in prone position, clamps and cuts cord. The baby is given to Pediatrics in the prone position. The infant will be kept in the prone position in transit to warmer and on warmer for first towel drying completed. Pulse oximetry and temperature probe will be placed. Vitals signs of HR, RR and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be documented.
- As toweling is changed the baby in prone position continues as such until five minutes pass. After five minutes the baby is turned to supine position as per standard NRP protocol.
- Decision to initiate positive pressure ventilation and /or oxygen supplementation will be guided by published NRP 2010 lower saturation targets (1 min <60%, 2 min <65%, 3 min <70%, 4 min <75%, 5 min <80%) and/or by grunting, retractions ; discontinuation by high saturation targets (1min >65%, 2 min >70%, 3min >>75%, 4 min >80%, 5 min >85%) and resolution of respiratory distress. Positive pressure ventilation will be delivered via Neopuff device in supine position (both groups); CPAP 5cm 21% initially, then the amount of oxygen will be titrated to meet oxygen saturation target for given minute of life.
- After no more than 30 minutes, Primary Assignment for admission to the NBN vs. NICU is made by a trained member of the study who was not in the operating room at the beginning of the delivery when the initial positioning of the infant was revealed. This is possible with 24 hour coverage from attendings, fellows, and mid-level practioners. Determination is based on Weiler NICU admission protocols.
- If infant is to go to NBN then STS and breastfeeding protocols will be followed.
- Infants developing respiratory distress in the NBN will be transferred to the NICU for further evaluation and care 12. Infants admitted to NICU directly or via NBN would have vital signs monitored as per NICU nursing protocol until discharge 13. Documentation of Length of Stay in NBN or NICU will collected 14. Documentation of intensity of care, type of support, maximum FiO2 required and duration of respiratory support in NICU will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prone | Experimental | Other: positioningProne positioned after delivery |
| supine | Active comparator | Other: positioningSupine positioned after delivery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Obstetrical patients delivering at Weiler Hospital.
- Any woman not in labor, who is undergoing scheduled caesarean deliveries at term (37 - 42 completed weeks of gestation),
Key exclusion criteria (7 listed)
- Women with prior rupture of membranes
- Women receiving magnesium sulfate
- Women with known illegal drug history
- fetus with known congenital anomalies or if meconium stained fluid is present.
- mother with maternal fever, chorioamnionitis
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 |
|---|---|---|
| positioningprone positioning for the initial 5 minutes of life | Other | prone |
| positioningsupine positioning for the initial 5 minutes of life | Other | supine |
Primary outcome
Administration of positive pressure ventilation and/or oxygen in prone vs supine groups
Time frame: 30 minutes
any administration of positive pressure ventilation and /or oxygen
4 secondary outcomes
Differences in pulse oximetry recordings between prone and supine groups
Time frame: 5 minutes
Differences in heart rate between prone and supine groups
Time frame: 5 minutes
Differences in respiratory rate between prone and supine groups
Time frame: 5 minutes
Differences in neonatal intensive care admission rates between prone and supine groups
Time frame: 30 minutes
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 5 Feb 2019.
- Individual participant dataSharing planned: No
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.
Thomas Havranek, MD principal investigator
Albert Einstein University/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 positioning in people with Prone vs Supine Effects on Respiratory Outcomes, 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 2 inclusion and 7 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 5 Feb 2019. 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?
Administration of positive pressure ventilation and/or oxygen in prone vs supine groups (time frame: 30 minutes). 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 5 Feb 2019.