NCT02819414

Brief Summary

The therapeutic approach to the patent ductus arteriosus (PDA) in the premature neonate remains controversial. Currently it is generally accepted to treat only hemodynamically significant PDAs. The current investigation aims to study the effect of treatment on PDAs of borderline significance via a prospective, randomized controlled trial of paracetamol in this group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

June 28, 2016

Last Update Submit

July 2, 2016

Conditions

Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

  • Composite outcome of death or severe morbidity chronic lung disease [CLD]

    Chronic lung disease will be assessed by time on supplemental oxygen and assisted ventilation.

    Day of life 3 until 40 weeks post-conception

Secondary Outcomes (2)

  • Subsequently diagnosed hs PDA

    Completion of study intervention until 40 weeks post-conception

  • Subsequent incidence of necrotizing enterocolitis (NEC) and/or retinopathy of prematurity (ROP)

    Completion of study intervention until 40 weeks post-conception

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Treatment with placebo at a volume of 2.25 cc/kg/dose x 4/day to be given with feeds, or in place of feed when baby is receiving \<2 cc/kg/feed.

Other: Placebo

Treatment Group

ACTIVE COMPARATOR

Treatment with paracetamol drops at 15 mg/kg/dose x 4/day. Drops will be diluted 1:15 in order to reduce osmolality. This will yield a dose of 2.25 ml/kg/dose, to be given with feeds, or in place of feed when baby is receiving \<2 cc/kg/feed.

Drug: Paracetamol drops

Interventions

Paracetamol dropsDRUG

15 mg/kg/dose x 4/day diluted 1:15 yielding dose of 2.25 ml/kg/dose to be given for three days

Also known as: Novimol
Treatment Group
PlaceboOTHER

2.25 ml/kg/dose x 4/day of sterile water to be given for three days

Control Group

Eligibility Criteria

Age3 Days - 6 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm neonates \< 30 weeks' gestational age PDA of borderline significance

You may not qualify if:

  • Infants not deemed likely to survive more than one week Infants with congenital heart malformations Infants with pulmonary hypertension and right to left ductal shunting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (2)

  • Terrin G, Conte F, Oncel MY, Scipione A, McNamara PJ, Simons S, Sinha R, Erdeve O, Tekgunduz KS, Dogan M, Kessel I, Hammerman C, Nadir E, Yurttutan S, Jasani B, Alan S, Manguso F, De Curtis M. Paracetamol for the treatment of patent ductus arteriosus in preterm neonates: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2016 Mar;101(2):F127-36. doi: 10.1136/archdischild-2014-307312. Epub 2015 Aug 17.

    PMID: 26283668RESULT

  • Hammerman C, Bin-Nun A, Markovitch E, Schimmel MS, Kaplan M, Fink D. Ductal closure with paracetamol: a surprising new approach to patent ductus arteriosus treatment. Pediatrics. 2011 Dec;128(6):e1618-21. doi: 10.1542/peds.2011-0359. Epub 2011 Nov 7.

    PMID: 22065264RESULT

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Cathy Hammerman, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Div. Newborn Nurseries

Study Record Dates

First Submitted

June 28, 2016

First Posted

June 30, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

January 1, 2019

Last Updated

July 6, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)