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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pedi-Cap | Experimental | A Pedi-Cap will be connected to the T-piece resuscitator in between the T-piece and face mask. With effective gas exchange, carbon dioxide (CO2) is detected by the Pedi-cap and will demonstrate gold color change with each exhalation. If there is no CO2 gas exchanged, the Pedi-Cap color will remain purple. The color change will be used as one of the tools for the resuscitation team to determine if the infant has effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation. Other ways, in addition to the Pedi-Cap, to determine effective PPV include a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation. |
|
| No Pedi-Cap | No Intervention | There will be no Pedi-Cap attached to the t-piece resuscitator. Effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation will be assessed by a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pedi-Cap | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of positive pressure ventilation (PPV) | The time that an infant needs non-invasive PPV during delivery room resuscitation. | From birth to end of delivery room resuscitation or admission to the Neonatal Intensive Care Unit (NICU) (approximately 1 hour of life) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of bradycardia | The time that an infant has a heart rate of less than 100 beat per minute during delivery room resuscitation. | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) |
| Time to heart rate great than 100 beats per minute |
| Measure | Description | Time Frame |
|---|---|---|
| Initial heart rate at birth | The initial heart rate in beats per minute at the first recording after birth | From birth to initial assessment by resuscitation team members (approximately by 2 minutes of life) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Riti Chokshi | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Health | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33084392 | Background | Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres J, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020 Oct 20;142(16_suppl_1):S185-S221. doi: 10.1161/CIR.0000000000000895. Epub 2020 Oct 21. | |
| 20956431 |
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| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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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.
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The ultimate goal of a successful delivery room resuscitation is to sustain the infant's heart rate above 100 beats per minute. |
| From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) |
| time to start of ventilatory corrective maneuvers | 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. | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) |
| Maximum peak inspiratory pressure used | 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. | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) |
| Time to gold color change on Pedi-Cap | Gold color change on the Pedi-Cap indicates carbon dioxide (CO2) exchange occurring and correlates with increased tidal volumes and increased heart rate. | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) |
| Need for intubation in the delivery room | 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. | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) |
| need for delayed positive pressure ventilation | Need for a subsequent positive pressure ventilation after an initial cessation | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) |
| Need for chest compressions or epinephrine | 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. | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) |
| Need for neonatal intensive care unit admission if infant ≥35 gestational age | Generally, infants born ≥35 gestational age are not admitted to the neonatal intensive care unit unless there are delivery room complications or neonatal disease. | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) |
| Occurrence of pneumothorax | The risk of positive pressure ventilation can be a pneumothorax. | From birth to 3 days of life |
| Duration of mechanical ventilation | The number of days and infant requires mechanical ventilation | From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks |
| Need for surfactant | The need for surfactant administration | From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks |
| Maximum positive end expiratory pressure used | 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. | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) |
| Maximum fractionated inspired oxygen used | 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. | From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life) |
| Survival to discharge | Determination if the infant is discharged home | birth to discharge from NICU (up to 12 months of age) |
| Background |
| Perlman JM, Wyllie J, Kattwinkel J, Atkins DL, Chameides L, Goldsmith JP, Guinsburg R, Hazinski MF, Morley C, Richmond S, Simon WM, Singhal N, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Neonatal resuscitation: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Pediatrics. 2010 Nov;126(5):e1319-44. doi: 10.1542/peds.2010-2972B. Epub 2010 Oct 18. No abstract available. |
| Background | Weiner MDFGM. NRP Textbook of Neonatal Resuscitation. 8th. ed. Itasca: American Academy of Pediatrics; 2021. |
| Background | ILCOR Summary Statement: 2023 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendation 2023 [Available from: https://ilcor.org/publications/preprint |