Resuscitation
Conditions
Keywords
Bag and mask, Neopuff, Resuscitation, Newborn, Intubation, devices, PEEP
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 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.
Interventions
DEVICET-piece resuscitator Neopuff TM
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.
DEVICESelf Inflating Bag with PEEP
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.
DEVICESelf Inflating Bag without PEEP
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.
Sponsors
University of Alabama at Birmingham
Edgardo Szyld
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Minutes
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life. | 2 minutes of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • 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 | 1-5 minutes of life | 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. |
| • Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat) | first week of life | — |
| • Incidence of Air Leaks | after birth and during hospitalization up to four weeks | included pneumothorax and Pneumomediastinum |
| Time the Newborn Takes to Reach a HR > 100 Bpm | 2 minutes of life | — |
| 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 | 1 day of life and 30 days after birth | Incidence of intracranial hemorrhage grades 3-4 for preterm newborns \<32 weeks by ultrasound evaluation |
| • Use of Oxygen Treatment Beyond the Delivery Room | during hospitalization | — |
Countries
Argentina, Chile, Italy, Peru, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T-Piece Subjects assigned to be resuscitated with T-Piece | 511 |
| Self Inflating Bag With PEEP Subjects allocated to Self Inflating Bag with PEEP | 290 |
| Self Inflating Bag Without PEEP Subjects allocated to Self Inflating Bag without PEEP | 226 |
| Total | 1,027 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | unknown primary outcome | 3 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | T-Piece | Self Inflating Bag With PEEP | Self Inflating Bag Without PEEP | Total |
|---|---|---|---|---|
| Age, Continuous | 36 weeks STANDARD_DEVIATION 4.1 | 35 weeks STANDARD_DEVIATION 5 | 37 weeks STANDARD_DEVIATION 4 | 36 weeks STANDARD_DEVIATION 4.2 |
| ANTENATAL STEROIDS NO | 369 participants | 206 participants | 154 participants | 729 participants |
| ANTENATAL STEROIDS YES | 142 participants | 84 participants | 72 participants | 298 participants |
| previous deliveries multiparous | 291 number of participants | 153 number of participants | 120 number of participants | 564 number of participants |
| previous deliveries primiparous | 220 number of participants | 137 number of participants | 106 number of participants | 463 number of participants |
| Sex: Female, Male Female | 208 Participants | 117 Participants | 101 Participants | 426 Participants |
| Sex: Female, Male Male | 303 Participants | 173 Participants | 125 Participants | 601 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 511 | 25 / 290 | 19 / 226 |
| serious Total, serious adverse events | 11 / 511 | 8 / 290 | 7 / 226 |
Outcome results
Primary
Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.
Time frame: 2 minutes of life
Population: The analysis was performed by intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Piece | Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life. | 93.7 percentage of participants |
| SIB - Self Inflating Bag With PEEP Valve | Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life. | 88 percentage of participants |
| SIB-Without PEEP Valve | Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life. | 93 percentage of participants |
Secondary
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.
Time frame: 1-5 minutes of life
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-Piece | Apgar Scores at 1 and 5 Minutes | apgar score 5 min <=5 | 30 participants |
| T-Piece | Apgar Scores at 1 and 5 Minutes | apgar score 1 min <=3 | 153 participants |
| SIB - Self Inflating Bag With PEEP Valve | Apgar Scores at 1 and 5 Minutes | apgar score 5 min <=5 | 24 participants |
| SIB - Self Inflating Bag With PEEP Valve | Apgar Scores at 1 and 5 Minutes | apgar score 1 min <=3 | 111 participants |
| SIB-Without PEEP Valve | Apgar Scores at 1 and 5 Minutes | apgar score 1 min <=3 | 66 participants |
| SIB-Without PEEP Valve | Apgar Scores at 1 and 5 Minutes | apgar score 5 min <=5 | 23 participants |
Secondary
Days on CPAP
Time frame: after birth and during hospitalization up to four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-Piece | Days on CPAP | 7.83 days | Standard Deviation 11.3 |
| SIB - Self Inflating Bag With PEEP Valve | Days on CPAP | 9.6 days | Standard Deviation 11.5 |
| SIB-Without PEEP Valve | Days on CPAP | 5.2 days | Standard Deviation 6.5 |
Secondary
Days on Mechanical Ventilation
Time frame: after delivery and before four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-Piece | Days on Mechanical Ventilation | 5.0 days | Standard Deviation 7.6 |
| SIB - Self Inflating Bag With PEEP Valve | Days on Mechanical Ventilation | 7 days | Standard Deviation 11 |
| SIB-Without PEEP Valve | Days on Mechanical Ventilation | 12 days | Standard Deviation 17 |
Secondary
Days on Oxygen
Time frame: after birth and during hospitalization up to four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-Piece | Days on Oxygen | 13.8 days | Standard Deviation 17 |
| SIB - Self Inflating Bag With PEEP Valve | Days on Oxygen | 23 days | Standard Deviation 27 |
| SIB-Without PEEP Valve | Days on Oxygen | 23 days | Standard Deviation 22 |
Secondary
• Incidence of Air Leaks
included pneumothorax and Pneumomediastinum
Time frame: after birth and during hospitalization up to four weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Piece | • Incidence of Air Leaks | 13 participants |
| SIB - Self Inflating Bag With PEEP Valve | • Incidence of Air Leaks | 6 participants |
| SIB-Without PEEP Valve | • Incidence of Air Leaks | 2 participants |
Secondary
• 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
Time frame: 1 day of life and 30 days after birth
Population: this is an analyisis among the subgroup of subjects \<32 weeks GA. this is the population at risk of this outcome. It extremely unusual intracranial hemorrhage over 32 weeks GA.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T-Piece | • Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks | 10 Participants |
| SIB - Self Inflating Bag With PEEP Valve | • Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks | 1 Participants |
| SIB-Without PEEP Valve | • Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks | 3 Participants |
Secondary
• Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)
Time frame: first week of life
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Piece | • Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat) | 21 participants |
| SIB - Self Inflating Bag With PEEP Valve | • Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat) | 21 participants |
| SIB-Without PEEP Valve | • Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat) | 7 participants |
Secondary
• Need for Chest Compression and/or Medications
Time frame: after 2 minutes of life
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Piece | • Need for Chest Compression and/or Medications | 8 participants |
| SIB - Self Inflating Bag With PEEP Valve | • Need for Chest Compression and/or Medications | 11 participants |
| SIB-Without PEEP Valve | • Need for Chest Compression and/or Medications | 6 participants |
Secondary
• Need for Mechanical Ventilation or CPAP
Time frame: during hospitalization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Piece | • Need for Mechanical Ventilation or CPAP | 116 participants |
| SIB - Self Inflating Bag With PEEP Valve | • Need for Mechanical Ventilation or CPAP | 104 participants |
| SIB-Without PEEP Valve | • Need for Mechanical Ventilation or CPAP | 43 participants |
Secondary
• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.
Time frame: after 2 minutes of life
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Piece | • Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask. | 17 percentage of participants |
| SIB - Self Inflating Bag With PEEP Valve | • Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask. | 28 percentage of participants |
| SIB-Without PEEP Valve | • Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask. | 23 percentage of participants |
Secondary
• SpO2 Value at 2 Minutes of Life.
Time frame: 2 minutes of life
Population: the pulse-oximeter was reliable at 2 minutes in 69% of the cases in both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-Piece | • SpO2 Value at 2 Minutes of Life. | 82 percentage of oxygen saturation | Standard Deviation 14 |
| SIB - Self Inflating Bag With PEEP Valve | • SpO2 Value at 2 Minutes of Life. | 80 percentage of oxygen saturation | Standard Deviation 20 |
| SIB-Without PEEP Valve | • SpO2 Value at 2 Minutes of Life. | 77 percentage of oxygen saturation | Standard Deviation 16 |
Secondary
Time the Newborn Takes to Reach a HR > 100 Bpm
Time frame: 2 minutes of life
| Arm | Measure | Value (MEAN) |
|---|---|---|
| T-Piece | Time the Newborn Takes to Reach a HR > 100 Bpm | 1 minutes |
| SIB - Self Inflating Bag With PEEP Valve | Time the Newborn Takes to Reach a HR > 100 Bpm | 1 minutes |
| SIB-Without PEEP Valve | Time the Newborn Takes to Reach a HR > 100 Bpm | 1 minutes |
Secondary
• Use of Oxygen Treatment Beyond the Delivery Room
Time frame: during hospitalization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Piece | • Use of Oxygen Treatment Beyond the Delivery Room | 208 participants/ |
| SIB - Self Inflating Bag With PEEP Valve | • Use of Oxygen Treatment Beyond the Delivery Room | 126 participants/ |
| SIB-Without PEEP Valve | • Use of Oxygen Treatment Beyond the Delivery Room | 96 participants/ |