Hypotension in Preterm Infants (HIP) randomised trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F21%3A43921207" target="_blank" >RIV/00216208:11120/21:43921207 - isvavai.cz</a>
Alternative codes found
RIV/00023698:_____/21:N0000021 RIV/70883521:28150/21:63527558
Result on the web
<a href="https://doi.org/10.1136/archdischild-2020-320241" target="_blank" >https://doi.org/10.1136/archdischild-2020-320241</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1136/archdischild-2020-320241" target="_blank" >10.1136/archdischild-2020-320241</a>
Alternative languages
Result language
angličtina
Original language name
Hypotension in Preterm Infants (HIP) randomised trial
Original language description
OBJECTIVE: To determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation. DESIGN: Double-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment. SETTING: 10 sites across Europe and Canada. PARTICIPANTS: Infants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for GREATER-THAN OR EQUAL TO15 min in the first 72 hours of life and a cerebral ultrasound free of significant (GREATER-THAN OR EQUAL TO grade 3) intraventricular haemorrhage. INTERVENTION: Participants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management). PRIMARY OUTCOME: Survival to 36 weeks of PMA without severe brain injury. RESULTS: The trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038). CONCLUSION: Though this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area. TRIAL REGISTRATION NUMBER: NCT01482559, EudraCT 2010-023988-17.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30214 - Obstetrics and gynaecology
Result continuities
Project
—
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2021
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Archives of Disease in Childhood: Fetal and Neonatal Edition
ISSN
1359-2998
e-ISSN
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Volume of the periodical
106
Issue of the periodical within the volume
4
Country of publishing house
GB - UNITED KINGDOM
Number of pages
6
Pages from-to
398-403
UT code for WoS article
000670027100011
EID of the result in the Scopus database
2-s2.0-85101823629