Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443118
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2007-03-02
Brief Title:
Newborn Ventilation in the Delivery Room Could it be Improved With a T-piece Resuscitator
Sponsor:
Edgardo Szyld
Organization:
Fundacion para la Salud Materno Infantil
Study Overview
Official Title:
NEWBORN VENTILATION IN THE DELIVERY ROOM CAN IT BE IMPROVED WITH A T-PIECE RESUSCITATOR Multicenter Cross-over Cluster Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-08
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:
A multicenter cross-over cluster randomized controlled trial protocol study in newborn infants 26 weeks gestational age requiring assisted ventilation positive pressure ventilation PPV for resuscitation in the delivery room comparing a T-piece resuscitator device versus resuscitation bag
Detailed Description:
Design A multicenter cross-over cluster randomized controlled trial Our hypothesis is based on the assumption that ventilating depressed newborns with a T-piece resuscitator will be more effective than SIB by increasing the proportion of resuscitated newborns with heart rate HR 100 beats per minute bpm at two minutes of life as a proxy for successful resuscitation
Population Newborn infants 26 weeks gestational age requiring assisted ventilation PPV for resuscitation in the delivery room
need for assisted ventilation at positive pressure Heart Rate HR 100 beats per minute bpm apnea gasping cyanosis andor hypotonia
Intervention PPV will be performed with a T-piece resuscitator Neopuff group with positive end expiratory pressure
Control PPV will be performed with a self inflating bag SIB group with and without PEEP
Both devices will be used with face masks and a peak inspiratory pressure PIP of 25 cm H2O will be used to begin ventilation with PEEP of 0 cm H2O in the subgroup without PEEP valve 5 cm H2O in the subgroup with PEEP valve in the SIB group and 5 cm H2O in the Neopuff group
Objective To compare the effectiveness of both instruments in reaching a heart rate of 100 bpm in depressed newborns of 26 weeks gestational age GA after the initiation of positive pressure ventilation PPV with face mask
Primary Outcome Proportion of newborns with HR 100 bpm at 2 minutes of life
Type of Comparison Which of the two devices Neopuff TM or Self Inflating Bag NPSIBwill be more effective for ventilation of the newborn by increasing the proportion of resuscitated newborns with heart rate HR 100 beats per minute bpm at two minutes of life as a proxy for successful resuscitation
Population Newborn infants 26 weeks gestational age requiring assisted ventilation PPV for resuscitation in the delivery room
need for assisted ventilation at positive pressure Heart Rate HR 100 beats per minute bpm apnea gasping cyanosis andor hypotonia
Intervention PPV will be performed with a T-piece resuscitator Neopuff group with positive end expiratory pressure
Control PPV will be performed with a self inflating bag SIB group with and without PEEP
Both devices will be used with face masks and a peak inspiratory pressure PIP of 25 cm H2O will be used to begin ventilation with PEEP of 0 cm H2O in the subgroup without PEEP valve 5 cm H2O in the subgroup with PEEP valve in the SIB group and 5 cm H2O in the Neopuff group
Objective To compare the effectiveness of both instruments in reaching a heart rate of 100 bpm in depressed newborns of 26 weeks gestational age GA after the initiation of positive pressure ventilation PPV with face mask
Primary Outcome Proportion of newborns with HR 100 bpm at 2 minutes of life
Type of Comparison Which of the two devices Neopuff TM or Self Inflating Bag NPSIBwill be more effective for ventilation of the newborn by increasing the proportion of resuscitated newborns with heart rate HR 100 beats per minute bpm at two minutes of life as a proxy for successful resuscitation
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