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J Pediatr. 2019 Feb;205:41-48.e6. doi: 10.1016/j.jpeds.2018.09.012. Epub 2018 Oct 16.

PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age.

Author information

1
Department of Pediatrics, University of California San Francisco, San Francisco, CA; Cardiovascular Research Institute, University of California San Francisco, San Francisco, CA. Electronic address: clymanr@peds.ucsf.edu.
2
Department of Pediatrics, University of California San Francisco, San Francisco, CA.
3
Department of Pediatrics, Providence St. Vincent Medical Center, Portland, OR.
4
Department of Pediatrics, Ankara University School of Medicine Children's Hospital, Ankara, Turkey.
5
Department of Pediatrics, Sisli Hamidiye Etfal Training and Research Hospital, İstanbul, Turkey.
6
Department of Pediatrics, Umea University Hospital, Umea, Sweden.
7
Department of Pediatrics, Sharp Mary Birch Hospital, San Diego, CA.
8
Department of Pediatrics, University of Chicago, Chicago, IL.
9
Department of Pediatrics, Kaiser Permanente Santa Clara Medical Center, Santa Clara, CA.
10
Department of Pediatrics, Morristown Medical Center, Morristown, NJ.
11
Department of Pediatrics, Johns Hopkins University, Baltimore, MD.
12
Department of Pediatrics, University of Glasgow, Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom.
13
Department of Pediatrics, Mayo Clinic, Rochester, MN.
14
Department of Pediatrics, Northshore University Health System, Evanston, IL.
15
Department of Pediatrics, University of California San Diego and Rady Children's Hospital, San Diego, CA.
16
Department of Pediatrics, Good Samaritan Hospital, San Jose, CA.
17
Department of Pediatrics, Columbia University Medical Center, New York, NY.
18
Department of Pediatrics, South Miami Hospital/Baptist Health South Florida, Miami, FL.
19
University of California San Francisco, San Francisco, CA.
20
Providence St. Vincent Medical Center, Portland, OR.
21
Ankara University School of Medicine Children's Hospital, Ankara, Turkey.
22
Sisli Hamidiye Etfal Training and Research Hospital, İstanbul, Turkey.
23
Sharp Mary Birch Hospital, San Diego, CA.
24
University of Chicago, Chicago, IL.
25
Morristown Medical Center, Morristown, NJ.
26
Johns Hopkins Hospital, Baltimore, MD.
27
University of Glasgow, Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom.
28
Mayo Clinic, Rochester, MN.
29
Northshore University Health System, Evanston, IL.
30
University of California San Diego and Rady Children's Hospital, San Diego, CA.
31
Good Samaritan Hospital, San Jose, CA.
32
South Miami Hospital/Baptist Health South Florida, Miami, FL.
33
Columbia University Medical Center, New York, NY.
34
University of Southern California, Los Angeles, CA.
35
Vanderbilt University, Nashville, TN.

Abstract

OBJECTIVE:

To compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given.

STUDY DESIGN:

A total of 202 neonates of <28 weeks of gestation age (mean, 25.8 ± 1.1 weeks) with moderate-to-large PDA shunts were enrolled between age 6 and 14 days (mean, 8.1 ± 2.2 days) into an exploratory randomized controlled trial.

RESULTS:

At enrollment, 49% of the patients were intubated and 48% required nasal ventilation or continuous positive airway pressure. There were no differences between the groups in either our primary outcome of ligation or presence of a PDA at discharge (early routine treatment [ERT], 32%; conservative treatment [CT], 39%) or any of our prespecified secondary outcomes of necrotizing enterocolitis (ERT, 16%; CT, 19%), bronchopulmonary dysplasia (BPD) (ERT, 49%; CT, 53%), BPD/death (ERT, 58%; CT, 57%), death (ERT,19%; CT, 10%), and weekly need for respiratory support. Fewer infants in the ERT group met the rescue criteria (ERT, 31%; CT, 62%). In secondary exploratory analyses, infants receiving ERT had significantly less need for inotropic support (ERT, 13%; CT, 25%). However, among infants who were ≥26 weeks gestational age, those receiving ERT took significantly longer to achieve enteral feeding of 120 mL/kg/day (median: ERT, 14 days [range, 4.5-19 days]; CT, 6 days [range, 3-14 days]), and had significantly higher incidences of late-onset non-coagulase-negative Staphylococcus bacteremia (ERT, 24%; CT,6%) and death (ERT, 16%; CT, 2%).

CONCLUSIONS:

In preterm infants age <28 weeks with moderate-to-large PDAs who were receiving respiratory support after the first week, ERT did not reduce PDA ligations or the presence of a PDA at discharge and did not improve any of the prespecified secondary outcomes, but delayed full feeding and was associated with higher rates of late-onset sepsis and death in infants born at ≥26 weeks of gestation.

TRIAL REGISTRATION:

ClinicalTrials.gov: NCT01958320.

KEYWORDS:

bronchopulmonary dysplasia; necrotizing enterocolitis; newborn; premature birth; retinopathy of prematurity

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