NCT04469413

Brief Summary

The aim of this study was to evaluate the effect of paracetamol on patent ductus arteriosus (PDA) closure and clinical outcomes in preterm infants when used as standard intermittent bolus and continuous intravenous (IV) infusion. Preterm neonates with birth weight (BW) ≤1500 g and gestational age (GA) ≤32 weeks were included in this study. During the study period, IV paracetamol therapy was given to all infants with hemodynamically significant patent ductus arteriosus (hsPDA). The patients were divided into the standard IV intermittent bolus infusion group and the continuous IV infusion group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

July 9, 2020

Last Update Submit

July 9, 2020

Conditions

Patent Ductus Arteriosus in Preterm Infants

Outcome Measures

Primary Outcomes (1)

  • Patent Ductus Arteriosus

    PDA-related morbidities, multiple paracetamol courses, and PDA ligation

    6 months

Study Arms (2)

standard IV intermittent bolus infusion group

Drug: Paracetamol Infusion

continuousIV intermittent bolus infusion group

Drug: Paracetamol Infusion

Interventions

Paracetamol InfusionDRUG

Continuous and Standard Intermittent Boluses Paracetamol Infusion

continuousIV intermittent bolus infusion groupstandard IV intermittent bolus infusion group

Eligibility Criteria

AgeUp to 1 Month
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm preterms with birth weight (BW) ≤1500 g and gestational age (GA) ≤32 weeks will be included in the study.

You may qualify if:

  • birth weight (BW) ≤1500 g and gestational age (GA) ≤32 weeks at birth

You may not qualify if:

  • birth weight (BW) \>1500 g and gestational age (GA) \>32 weeks at birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk Cakir

Ankara, 06130, Turkey (Türkiye)

Location

Related Publications (1)

  • Cakir U, Tayman C, Karacaglar NB, Beser E, Ceran B, Unsal H. Comparison of the effect of continuous and standard intermittent bolus paracetamol infusion on patent ductus arteriosus. Eur J Pediatr. 2021 Feb;180(2):433-440. doi: 10.1007/s00431-020-03822-1. Epub 2020 Sep 29.

    PMID: 32995919DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ankara University

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 14, 2020

Study Start

January 1, 2019

Primary Completion

August 1, 2019

Study Completion

January 6, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

TU(1)