Neonatal Disease, Neonatal Resuscitation
Conditions
Brief summary
The goal of this study is to determine if using a Pedi-Cap (a type of colorimetric carbon dioxide detector) during face mask ventilation (PPV) for newborn infants in the delivery room will lower the time of PPV needed. A group of nurses, doctors, and respiratory therapists, called the neonatal resuscitation team, will either use or not use the Pedi-Cap during face mask PPV for infants born at ≥30 weeks' gestation. A randomization generator will assign each month to either use the Pedi-Cap or not use the Pedi-Cap. The researchers will collect information from the medical chart to find the infant and mother's information, medical interventions done in the delivery room, and lab values. In addition, resuscitation team members will fill out a survey of their experiences of using or not using the Pedi-Cap during delivery room facemask PPV.
Detailed description
This is an open, prospective, quasi-randomized, single center trial that will address the primary research question: Does use of a colorimetric carbon dioxide (CO2) detector (Pedi-Cap) decrease the duration of non-invasive positive pressure ventilation (PPV) in the delivery room? The neonatal resuscitation team, comprised of nurses, doctors, and respiratory therapists will include or omit the Pedi-Cap during noninvasive PPV for infants born at ≥30 weeks' gestation in the delivery room. The quasi-randomization scheme will be determined by a opening an opaque envelope each month. This will be revealed at the beginning of each month on whether to use the Pedi-Cap or not. Other outcomes variables that will be assessed include initial heart rate (HR), time to HR \> 100 bpm, duration of bradycardia, time to start of ventilation corrective maneuvers (if needed), maximum peak inspiratory pressure used, maximum peek inspiratory pressure used, maximum fractionated inspired oxygen, time to gold color change on Pedi-Cap, need for intubation, need for delayed PPV, need for chest compressions/epinephrine, need for neonatal intensive care unit admission if infant ≥35 gestational age, occurrence of pneumothorax, length of mechanical ventilation in days, doses of surfactant given, and survival to discharge. Infant and maternal characteristics will be obtained from the electronic medical record. Association of outcomes with each study arm will be stratified by infant and maternal characteristics. In addition, a survey will be administered to the resuscitation team members at the completion of the study to assess their experience with each study arm.
Interventions
DEVICEPedi-Cap
The neonatal resuscitation team will include or omit the use of Pedi-Cap during non-invasive positive pressure ventilation (PPV) for infants ≥30 weeks in the delivery room based on the randomized study arm each month.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The quasi-randomization scheme will be determined by a non-investigator for each month. This will be revealed at the beginning of each month on whether to use Pedi-Cap or not during delivery room resuscitation using sealed, opaque envelopes.
Eligibility
Sex/Gender
ALL
Age
30 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
* Infants born at ≥30 weeks' gestation * Presence of the resuscitation team prior to delivery * Need for non-invasive positive pressure ventilation (PPV).
Exclusion criteria
* Infants born at \<30 weeks' gestation * No non-invasive PPV needed in the delivery room * Infants with conditions requiring immediate intubation such as congenital diaphragmatic hernia * Resuscitation team not present prior to delivery/need for PPV * Infants who have a prenatal plan of comfort care only
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of positive pressure ventilation (PPV) | From birth to end of delivery room resuscitation or admission to the Neonatal Intensive Care Unit (NICU) (approximately 1 hour of life) | The time that an infant needs non-invasive PPV during delivery room resuscitation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of bradycardia | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) | The time that an infant has a heart rate of less than 100 beat per minute during delivery room resuscitation. |
| Time to heart rate great than 100 beats per minute | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) | The ultimate goal of a successful delivery room resuscitation is to sustain the infant's heart rate above 100 beats per minute. |
| time to start of ventilatory corrective maneuvers | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) | As per the neonatal resuscitation program algorithm 8th edition, if the infant's heart rate does not improve with non-invasive ventilation, corrective steps must be taken to optimize non-invasive ventilation such as suctioning, repositioning, adjusting the mask, opening the mouth/nose, and increasing the peak inspiratory pressure. |
| Maximum peak inspiratory pressure used | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) | As per the neonatal resuscitation program algorithm 8th edition, if the infant's heart rate does not improve with non-invasive ventilation, corrective steps must be taken to optimize non-invasive ventilation such as increasing peak inspiratory pressure. |
| Time to gold color change on Pedi-Cap | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) | Gold color change on the Pedi-Cap indicates carbon dioxide (CO2) exchange occurring and correlates with increased tidal volumes and increased heart rate. |
| Need for intubation in the delivery room | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) | Need for intubation as per the neonatal resuscitation program algorithm 8th edition if the infant's heart rate does not improve with non-invasive ventilation. |
| need for delayed positive pressure ventilation | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) | Need for a subsequent positive pressure ventilation after an initial cessation |
| Need for chest compressions or epinephrine | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) | Need for chest compression and epinephrine as per the neonatal resuscitation program algorithm 8th edition if the infant's heart rate does not improve with invasive ventilation. |
| Need for neonatal intensive care unit admission if infant ≥35 gestational age | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) | Generally, infants born ≥35 gestational age are not admitted to the neonatal intensive care unit unless there are delivery room complications or neonatal disease. |
| Occurrence of pneumothorax | From birth to 3 days of life | The risk of positive pressure ventilation can be a pneumothorax. |
| Duration of mechanical ventilation | From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks | The number of days and infant requires mechanical ventilation |
| Need for surfactant | From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks | The need for surfactant administration |
| Maximum positive end expiratory pressure used | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) | As per the neonatal resuscitation program algorithm 8th edition, if the infant does not have good oxygen saturation, interventions must be done to meet goal saturations for each minute of life. |
| Maximum fractionated inspired oxygen used | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) | As per the neonatal resuscitation program algorithm 8th edition, if the infant does not have good oxygen saturation, interventions must be done to meet goal saturations for each minute of life. |
| Survival to discharge | birth to discharge from NICU (up to 12 months of age) | Determination if the infant is discharged home |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRiti Chokshi
University of Texas
Outcome results
None listed