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JAMA. 2019 Mar 26;321(12):1165-1175. doi: 10.1001/jama.2019.1660.

Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial.

Author information

1
Division of Neonatology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia.
2
Division of Biostatistics, Department of Public Health Sciences, University of Virginia, Charlottesville.
3
Warren Alpert Medical School, Department of Pediatrics, Brown University Women and Infants Hospital of Rhode Island, Providence.
4
Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia.
5
Division of Neonatology, Department of Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia.
6
Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, the Netherlands.
7
Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
8
Division of Neonatology, Department of Pediatrics, Children's Hospital of Philadelphia, Hospital of the University of Pennsylvania, Philadelphia.
9
Department of Neonatology, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.
10
Newborn Research Center and Neonatal Services, The Royal Women's Hospital, Melbourne, Victoria, Australia.
11
Department of Obstetrics and Gynecology, The University of Melbourne, Melbourne, Victoria, Australia.
12
Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
13
Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.
14
Department of Neonatology, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California.
15
Division of Neonatology, Department of Pediatrics, Sidra Medicine, Doha, Qatar.
16
Division of Neonatology and Pediatric Critical Care, Department of Pediatrics and Adolescent Medicine, Ulm University, Ulm, Germany.
17
Department of Pediatrics, NICU, Ospedale dei Bambini V. Buzzi, ASST-FBF-Sacco, Milan, Italy.
18
Division of Newborn Pediatrics, Pennsylvania Hospital, Philadelphia.
19
Center for Pediatrics, Medical Center-University of Freiburg, Faculty of Medicine, Freiburg, Germany.
20
Department of Pediatrics, Academic Teaching Hospital, Landeskrankenhaus Feldkirch, Feldkirch, Austria.
21
Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
22
Division of Neonatology, Department of Pediatrics, University of California, Davis, Sacramento.
23
Division of Neonatal-Perinatal Medicine, Department of Pediatrics, C.S. Mott Children's Hospital, Michigan Medicine, University of Michigan, Ann Arbor.
24
Division of Neonatology, Department of Pediatrics, Seoul National University Children's Hospital, Seoul, Republic of Korea.
25
Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
26
Department of Neonatology, WakeMed Health and Hospitals, Raleigh, North Carolina.
27
Department of Neonatology, KK Women's and Children's Hospital, Singapore.
28
Department of Pediatrics, Tufts Clinical and Translational Research Institute, The Floating Hospital for Children at Tufts Medical Center, Boston, Massachusetts.
29
Christiana Care Health System, Newark, Delaware.
30
Newborn Services, Mater Mothers' Hospital and Mater Research, South Brisbane, Queensland, Australia.
31
Division of Neonatology, Department of Pediatrics, Loma Linda University, Loma Linda, California.
32
Department of Pediatrics, Saitama Medical Center, Saitama Medical University, Kawagoe, Saitama, Japan.

Abstract

Importance:

Preterm infants must establish regular respirations at delivery. Sustained inflations may establish lung volume faster than short inflations.

Objective:

To determine whether a ventilation strategy including sustained inflations, compared with standard intermittent positive pressure ventilation, reduces bronchopulmonary dysplasia (BPD) or death at 36 weeks' postmenstrual age without harm in extremely preterm infants.

Design, Setting, and Participants:

Unmasked, randomized clinical trial (August 2014 to September 2017, with follow-up to February 15, 2018) conducted in 18 neonatal intensive care units in 9 countries. Preterm infants 23 to 26 weeks' gestational age requiring resuscitation with inadequate respiratory effort or bradycardia were enrolled. Planned enrollment was 600 infants. The trial was stopped after enrolling 426 infants, following a prespecified review of adverse outcomes.

Interventions:

The experimental intervention was up to 2 sustained inflations at maximal peak pressure of 25 cm H2O for 15 seconds using a T-piece and mask (n = 215); standard resuscitation was intermittent positive pressure ventilation (n = 211).

Main Outcome and Measures:

The primary outcome was the rate of BPD or death at 36 weeks' postmenstrual age. There were 27 prespecified secondary efficacy outcomes and 7 safety outcomes, including death at less than 48 hours.

Results:

Among 460 infants randomized (mean [SD] gestational age, 25.30 [0.97] weeks; 50.2% female), 426 infants (92.6%) completed the trial. In the sustained inflation group, 137 infants (63.7%) died or survived with BPD vs 125 infants (59.2%) in the standard resuscitation group (adjusted risk difference [aRD], 4.7% [95% CI, -3.8% to 13.1%]; P = .29). Death at less than 48 hours of age occurred in 16 infants (7.4%) in the sustained inflation group vs 3 infants (1.4%) in the standard resuscitation group (aRD, 5.6% [95% CI, 2.1% to 9.1%]; P = .002). Blinded adjudication detected an imbalance of rates of early death possibly attributable to resuscitation (sustained inflation: 11/16; standard resuscitation: 1/3). Of 27 secondary efficacy outcomes assessed by 36 weeks' postmenstrual age, 26 showed no significant difference between groups.

Conclusions and Relevance:

Among extremely preterm infants requiring resuscitation at birth, a ventilation strategy involving 2 sustained inflations, compared with standard intermittent positive pressure ventilation, did not reduce the risk of BPD or death at 36 weeks' postmenstrual age. These findings do not support the use of ventilation with sustained inflations among extremely preterm infants, although early termination of the trial limits definitive conclusions.

Trial Registration:

clinicaltrials.gov Identifier: NCT02139800.

PMID:
30912836
PMCID:
PMC6439695
[Available on 2019-09-26]
DOI:
10.1001/jama.2019.1660
[Indexed for MEDLINE]

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