NCT02692573

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2018

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

February 16, 2016

Last Update Submit

February 3, 2019

Conditions

Prone vs Supine Effects on Respiratory Outcomes

Outcome Measures

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

    30 minutes

Secondary Outcomes (4)

  • Differences in pulse oximetry recordings between prone and supine groups

    5 minutes

  • Differences in heart rate between prone and supine groups

    5 minutes

  • Differences in respiratory rate between prone and supine groups

    5 minutes

  • Differences in neonatal intensive care admission rates between prone and supine groups

    30 minutes

Study Arms (2)

prone

EXPERIMENTAL

Prone positioned after delivery

Other: positioning

supine

ACTIVE COMPARATOR

Supine positioned after delivery

Other: positioning

Interventions

positioningOTHER

prone positioning for the initial 5 minutes of life

prone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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),

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weiler Hospital

The Bronx, New York, 10461, United States

Location

MeSH Terms

Interventions

Patient Positioning

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Thomas Havranek, MD

    Albert Einstein University/Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Neonatologist, Associate Professor of Pediatrics

Study Record Dates

First Submitted

February 16, 2016

First Posted

February 26, 2016

Study Start

December 1, 2015

Primary Completion

December 2, 2018

Study Completion

December 18, 2018

Last Updated

February 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)