Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial.
Bronchopulmonary dysplasia
Echocardiography
Ibuprofen
Newborn
PDA
Patent ductus arteriosus
Preterm
Journal
BMC pediatrics
ISSN: 1471-2431
Titre abrégé: BMC Pediatr
Pays: England
ID NLM: 100967804
Informations de publication
Date de publication:
26 02 2021
26 02 2021
Historique:
received:
18
12
2020
accepted:
15
02
2021
entrez:
27
2
2021
pubmed:
28
2
2021
medline:
28
5
2021
Statut:
epublish
Résumé
The question of whether to treat patent ductus arteriosus (PDA) early or wait until symptoms appear remains high on the research agenda for neonatal medicine. Around 7000 extremely preterm babies under 29 weeks' gestation are born in the UK every year. In 40% of cases the PDA will fail to close spontaneously, even by 4 months of age. Untreated PDA can be associated with several serious and life-threatening short and long-term complications. Reliable data to support clinical decisions about PDA treatment are needed to prevent serious complications in high risk babies, while minimising undue exposure of infants. With the availability of routine bedside echocardiography, babies with a large PDA can be diagnosed before they become symptomatic. This is a multicentre, masked, randomised, placebo-controlled parallel group trial to determine if early-targeted treatment of a large PDA with parenteral ibuprofen in extremely preterm babies (23 Prophylactic pharmacological treatment of all preterm babies unnecessarily exposes them to potentially serious side effects of drug treatment, when their PDA may have closed spontaneously. However, delaying treatment until babies become symptomatic could result in loss of treatment benefit as irreversible damage may have already been done. Targeted, early pharmacological treatment of PDA in asymptomatic babies has the potential to overcome the disadvantages of both prophylactic (overtreatment) and symptomatic approaches (potentially too late). This could result in improvements in the clinically important short-term clinical (mortality and moderate or severe BPD at 36 weeks' postmenstrual age) and long-term health outcomes (moderate or severe neurodevelopment disability and respiratory morbidity) measured at 2 years corrected age. ISRCTN84264977 . Date assigned: 15/09/2010.
Sections du résumé
BACKGROUND
The question of whether to treat patent ductus arteriosus (PDA) early or wait until symptoms appear remains high on the research agenda for neonatal medicine. Around 7000 extremely preterm babies under 29 weeks' gestation are born in the UK every year. In 40% of cases the PDA will fail to close spontaneously, even by 4 months of age. Untreated PDA can be associated with several serious and life-threatening short and long-term complications. Reliable data to support clinical decisions about PDA treatment are needed to prevent serious complications in high risk babies, while minimising undue exposure of infants. With the availability of routine bedside echocardiography, babies with a large PDA can be diagnosed before they become symptomatic.
METHODS
This is a multicentre, masked, randomised, placebo-controlled parallel group trial to determine if early-targeted treatment of a large PDA with parenteral ibuprofen in extremely preterm babies (23
DISCUSSION
Prophylactic pharmacological treatment of all preterm babies unnecessarily exposes them to potentially serious side effects of drug treatment, when their PDA may have closed spontaneously. However, delaying treatment until babies become symptomatic could result in loss of treatment benefit as irreversible damage may have already been done. Targeted, early pharmacological treatment of PDA in asymptomatic babies has the potential to overcome the disadvantages of both prophylactic (overtreatment) and symptomatic approaches (potentially too late). This could result in improvements in the clinically important short-term clinical (mortality and moderate or severe BPD at 36 weeks' postmenstrual age) and long-term health outcomes (moderate or severe neurodevelopment disability and respiratory morbidity) measured at 2 years corrected age.
TRIAL REGISTRATION
ISRCTN84264977 . Date assigned: 15/09/2010.
Identifiants
pubmed: 33637074
doi: 10.1186/s12887-021-02558-7
pii: 10.1186/s12887-021-02558-7
pmc: PMC7908699
doi:
Substances chimiques
Ibuprofen
WK2XYI10QM
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
100Subventions
Organisme : Health Technology Assessment Programme
ID : 11/92/15
Commentaires et corrections
Type : ErratumIn
Références
Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F505-10
pubmed: 23893268
Arch Dis Child Fetal Neonatal Ed. 2008 Mar;93(2):F94-9
pubmed: 17768157
Pediatrics. 2009 Jan;123(1):e138-44
pubmed: 19117835
J Pediatr. 2006 Jun;148(6):730-734
pubmed: 16769377
Lancet Child Adolesc Health. 2019 Oct;3(10):705-712
pubmed: 31402196
Am J Perinatol. 2008 Nov;25(10):661-6
pubmed: 18850514
Neonatology. 2013;103(3):166-9
pubmed: 23258386
J Perinatol. 2010 Oct;30 Suppl:S31-7
pubmed: 20877405
N Engl J Med. 2001 Jun 28;344(26):1966-72
pubmed: 11430325
Pediatrics. 2009 Feb;123(2):e312-27
pubmed: 19171583
Semin Perinatol. 2013 Apr;37(2):102-7
pubmed: 23582964