Trial Outcomes & Findings for Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator? (NCT NCT00443118)

NCT ID: NCT00443118

Last Updated: 2018-09-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1032 participants
• Primary outcome timeframe: 2 minutes of life
• Results posted on: 2018-09-28

Participant Flow

Participant milestones

Measure	T-Piece Subjects assigned to be resuscitated with T-Piece	SIB - With PEEP Valve Subjects allocated to SIB with a PEEP valve attached	SIB-Without PEEP Valve Self inflating bag without PEEP valve
Overall Study STARTED	515	291	226
Overall Study COMPLETED	511	290	226
Overall Study NOT COMPLETED	4	1	0

Reasons for withdrawal

Measure	T-Piece Subjects assigned to be resuscitated with T-Piece	SIB - With PEEP Valve Subjects allocated to SIB with a PEEP valve attached	SIB-Without PEEP Valve Self inflating bag without PEEP valve
Overall Study unknown primary outcome	3	1	0
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	Self Inflating Bag With PEEP n=290 Participants Subjects allocated to Self Inflating Bag with PEEP	Self Inflating Bag Without PEEP n=226 Participants Subjects allocated to Self Inflating Bag without PEEP	Total n=1027 Participants Total of all reporting groups
Age, Continuous	36 weeks STANDARD_DEVIATION 4.1 • n=5 Participants	35 weeks STANDARD_DEVIATION 5 • n=7 Participants	37 weeks STANDARD_DEVIATION 4 • n=5 Participants	36 weeks STANDARD_DEVIATION 4.2 • n=4 Participants
Sex: Female, Male Female	208 Participants n=5 Participants	117 Participants n=7 Participants	101 Participants n=5 Participants	426 Participants n=4 Participants
Sex: Female, Male Male	303 Participants n=5 Participants	173 Participants n=7 Participants	125 Participants n=5 Participants	601 Participants n=4 Participants
previous deliveries primiparous	220 number of participants n=5 Participants	137 number of participants n=7 Participants	106 number of participants n=5 Participants	463 number of participants n=4 Participants
previous deliveries multiparous	291 number of participants n=5 Participants	153 number of participants n=7 Participants	120 number of participants n=5 Participants	564 number of participants n=4 Participants
ANTENATAL STEROIDS YES	142 participants n=5 Participants	84 participants n=7 Participants	72 participants n=5 Participants	298 participants n=4 Participants
ANTENATAL STEROIDS NO	369 participants n=5 Participants	206 participants n=7 Participants	154 participants n=5 Participants	729 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 minutes of life

Population: The analysis was performed by intention to treat

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.	93.7 percentage of participants	88 percentage of participants	93 percentage of participants

SECONDARY outcome

Timeframe: 2 minutes of life

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
Time the Newborn Takes to Reach a HR > 100 Bpm	1 minutes Interval 0.5 to 1.6	1 minutes Interval 0.5 to 1.8	1 minutes Interval 0.5 to 1.9

SECONDARY outcome

Timeframe: 2 minutes of life

Population: the pulse-oximeter was reliable at 2 minutes in 69% of the cases in both groups.

Outcome measures

Measure	T-Piece n=350 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=199 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=155 Participants Subjects allocated to SIB-Without PEEP valve attached
• SpO2 Value at 2 Minutes of Life.	82 percentage of oxygen saturation Standard Deviation 14	80 percentage of oxygen saturation Standard Deviation 20	77 percentage of oxygen saturation Standard Deviation 16

SECONDARY outcome

Timeframe: after 2 minutes of life

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.	17 percentage of participants	28 percentage of participants	23 percentage of participants

SECONDARY outcome

Timeframe: after 2 minutes of life

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
• Need for Chest Compression and/or Medications	8 participants	11 participants	6 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
Apgar Scores at 1 and 5 Minutes apgar score 1 min <=3	153 participants	111 participants	66 participants
Apgar Scores at 1 and 5 Minutes apgar score 5 min <=5	30 participants	24 participants	23 participants

SECONDARY outcome

Timeframe: first week of life

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
• Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)	21 participants	21 participants	7 participants

SECONDARY outcome

Timeframe: after birth and during hospitalization up to four weeks

included pneumothorax and Pneumomediastinum

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
• Incidence of Air Leaks	13 participants	6 participants	2 participants

SECONDARY outcome

Timeframe: during hospitalization

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
• Use of Oxygen Treatment Beyond the Delivery Room	208 participants/	126 participants/	96 participants/

SECONDARY outcome

Timeframe: after birth and during hospitalization up to four weeks

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
Days on Oxygen	13.8 days Standard Deviation 17	23 days Standard Deviation 27	23 days Standard Deviation 22

SECONDARY outcome

Timeframe: during hospitalization

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
• Need for Mechanical Ventilation or CPAP	116 participants	104 participants	43 participants

SECONDARY outcome

Timeframe: after delivery and before four weeks

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
Days on Mechanical Ventilation	5.0 days Standard Deviation 7.6	7 days Standard Deviation 11	12 days Standard Deviation 17

SECONDARY outcome

Timeframe: after birth and during hospitalization up to four weeks

Outcome measures

Measure	T-Piece n=511 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=290 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=226 Participants Subjects allocated to SIB-Without PEEP valve attached
Days on CPAP	7.83 days Standard Deviation 11.3	9.6 days Standard Deviation 11.5	5.2 days Standard Deviation 6.5

SECONDARY outcome

Timeframe: 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.

Incidence of intracranial hemorrhage grades 3-4 for preterm newborns <32 weeks by ultrasound evaluation

Outcome measures

Measure	T-Piece n=90 Participants Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP Valve n=73 Participants Subjects allocated to SIB with PEEP valve attached	SIB-Without PEEP Valve n=34 Participants Subjects allocated to SIB-Without PEEP valve attached
• Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks	10 Participants	1 Participants	3 Participants

Adverse Events

T-Piece

Serious events: 11 serious events

Other events: 21 other events

Deaths: 0 deaths

SIB - Self Inflating Bag With PEEP

Serious events: 8 serious events

Other events: 25 other events

Deaths: 0 deaths

SIB Without PEEP

Serious events: 7 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	T-Piece n=511 participants at risk Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP n=290 participants at risk Subjects allocated to be ventilated with Self Inflating Bag with PEEP valve	SIB Without PEEP n=226 participants at risk Subjects allocated to be ventilated with Self Inflating Bag without PEEP valve
General disorders mortality	2.2% 11/511 • Number of events 11	2.8% 8/290 • Number of events 8	3.1% 7/226 • Number of events 7

Other adverse events

Measure	T-Piece n=511 participants at risk Subjects assigned to be resuscitated with T-Piece	SIB - Self Inflating Bag With PEEP n=290 participants at risk Subjects allocated to be ventilated with Self Inflating Bag with PEEP valve	SIB Without PEEP n=226 participants at risk Subjects allocated to be ventilated with Self Inflating Bag without PEEP valve
Respiratory, thoracic and mediastinal disorders bronchopulmonary dysplasia	4.1% 21/511 • Number of events 21	8.6% 25/290 • Number of events 25	8.4% 19/226 • Number of events 19

Additional Information

Edgardo Szyld MD, MSc

FUNDASAMIN-Fundacion para la Salud Materno Infantil

Phone: 5491144093095

Email: eszyld@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place