Ignite Creation Date:
2024-05-06 @ 8:15 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02692573
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2016-02-16
Brief Title:
Prone or Supine Effect After Caesarean Delivery on Respiratory Outcomes in Full Term Infants
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Prone or Supine Effect of Immediate Positioning After Scheduled Caesarean Delivery on Respiratory Outcomes in Full Term Infants
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infants 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:
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
6 When a Group A supine infants 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
7 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
8 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 andor 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
9 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
10 If infant is to go to NBN then STS and breastfeeding protocols will be followed
11 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
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
6 When a Group A supine infants 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
7 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
8 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 andor 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
9 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
10 If infant is to go to NBN then STS and breastfeeding protocols will be followed
11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None