Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?

Study Overview
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Brief Summary
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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
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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 and/or 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 (NP/SIB)will 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.

Official Title
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NEWBORN VENTILATION IN THE DELIVERY ROOM: CAN IT BE IMPROVED WITH A T-PIECE RESUSCITATOR? Multicenter Cross-over Cluster Randomized Controlled Trial

Conditions
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Resuscitation

Intervention / Treatment
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* Device: T-piece resuscitator Neopuff TM
* Device: Self Inflating Bag with PEEP
* Device: Self Inflating Bag without PEEP


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Live-born infants of ≥ 26 weeks' GA with HR < 100 bpm requiring resuscitation with positive pressure ventilation with mask in the delivery room according to the current AAP/AHA recommendations Exclusion Criteria: Infants requiring intubation from birth. Newborns of < 26 weeks´ GA. Newborns presenting major congenital malformations. Multiple births. Problems (difficulty or malfunctioning) with the device assigned.

Ages Eligible for Study
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Maximum Age: 2 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neopuff TM with PEEP<br>Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP | Device: T-piece resuscitator Neopuff TM<br>* Positive pressure ventilation will be performed with Neopuff® with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.<br>|
| Active Comparator: Self Inflating Bag with PEEP<br>Newborns ventilated for neonatal resuscitation using Self Inflating Bag with PEEP valve attached | Device: Self Inflating Bag with PEEP<br>* Positive pressure ventilation will be performed with Self Inflating Bag with PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.<br>* Other names: Ambu;|
| Active Comparator: Self Inflating Bag without PEEP<br>Newborns ventilated for neonatal resuscitationusing Self Inflating Bag without PEEP valve attached | Device: Self Inflating Bag without PEEP<br>* Positive pressure ventilation will be performed with Self Inflating Bag without PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.<br>* Other names: Ambu;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life. |  | 2 minutes of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time the Newborn Takes to Reach a HR > 100 Bpm |  | 2 minutes of life | 
| • SpO2 Value at 2 Minutes of Life. |  | 2 minutes of life | 
| • Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask. |  | after 2 minutes of life | 
| • Need for Chest Compression and/or Medications |  | after 2 minutes of life | 
| Apgar Scores at 1 and 5 Minutes | categorized Apgar score 1 min <=3 and categorized Apgar score 5 min <=5 The Apgar score is applied routinely by nurses and neonatologists to describe how vigorous the baby is at birth, it ranges from 0 to 10, with higher scores representing better outcomes. | 1-5 minutes of life | 
| • Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat) |  | first week of life | 
| • Incidence of Air Leaks | included pneumothorax and Pneumomediastinum | after birth and during hospitalization up to four weeks | 
| • Use of Oxygen Treatment Beyond the Delivery Room |  | during hospitalization | 
| Days on Oxygen |  | after birth and during hospitalization up to four weeks | 
| • Need for Mechanical Ventilation or CPAP |  | during hospitalization | 
| Days on Mechanical Ventilation |  | after delivery and before four weeks | 
| Days on CPAP |  | after birth and during hospitalization up to four weeks | 
| • Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks | Incidence of intracranial hemorrhage grades 3-4 for preterm newborns <32 weeks by ultrasound evaluation | 1 day of life and 30 days after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bag and mask, Neopuff, Resuscitation, Newborn, Intubation, devices, PEEP