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CompletedNCT02692573Updated Feb 5, 2019

Prone or Supine Effect After Caesarean Delivery on Respiratory Outcomes in Full Term Infants

An interventional study of positioning and positioning in Prone vs Supine Effects on Respiratory Outcomes, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-02-05.

Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Sex
All
01

Study 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. 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
  1. Consent obtained prior to actual operative delivery and anesthesia
  2. Prior to start of surgery an opaque envelope with random selection of post delivery position, supine or prone, is opened
  3. Pediatric team confirms with Obstetrician and delivery team the position in which the infant will be given to pediatrics
  4. 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.
  1. 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.

  1. 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.
  1. 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.
  1. 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.
  1. If infant is to go to NBN then STS and breastfeeding protocols will be followed.
  1. 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.
02

Conditions studied

  • Prone vs Supine Effects on Respiratory Outcomes
03

In context

Lead sponsor

Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.

Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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),

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
500 participants (actual)

Study arms

  • Experimental
    prone

    Prone positioned after delivery

    Other: positioning

  • Active comparator
    supine

    Supine positioned after delivery

    Other: positioning

Interventions

  • Otherpositioning

    prone positioning for the initial 5 minutes of life

  • Otherpositioning

    supine positioning for the initial 5 minutes of life

06

What researchers measure

Primary outcomes

  1. Administration of positive pressure ventilation and/or oxygen in prone vs supine groups

    any administration of positive pressure ventilation and /or oxygen

    Time frame: 30 minutes

Secondary outcomes

  1. 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.

    Time frame: 5 minutes

  2. 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

    Time frame: 5 minutes

  3. 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

    Time frame: 5 minutes

  4. 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.

    Time frame: 30 minutes

07

Study locations

1 site
  • Weiler Hospital
    Bronx, New York 10461, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02692573
Lead sponsor
Montefiore Medical Center
Responsible party
Thomas Havranek (Attending Neonatologist, Associate Professor of Pediatrics, Montefiore Medical Center) — Principal investigator
First posted
Feb 26, 2016
Start date
Dec 2015
Primary completion
Dec 2, 2018
Completion
Dec 18, 2018
Last update
Feb 5, 2019

Study contacts

Thomas Havranek, MD
principal investigator · Albert Einstein University/Montefiore Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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