Extremely Low Gestatonal Age Infants' Paracetamol Study

NCT03641209 | Completed Phase 1

• 1 other identifier: 39/2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In the present trial, early, intravenous paracetamol is compared to placebo in extremely premature or low birth weight infants in order to evaluate the effect on ductal closure.

Conditions

Prematurity; Extreme; Low Birthweight, Extremely (999 Grams or Less)

Keywords

acetaminophen; ductus arteriosus; NIRS; intravenous

Outcome Measures

Primary Outcomes (1)

• Ductal closure

  Postnatal age of the observed closure of ductus arteriosus

  Neonatal intensive care unit (NICU) treatment period up to 13 weeks

Secondary Outcomes (9)

• Near-infrared spectroscopy values

  Study drug period up to 10 days

• Paracetamol serum levels

  Study drug period up to 10 days

• Paracetamol side effects

  Neonatal intensive care unit (NICU) treatment period up to 13 weeks

• PDA

  Neonatal intensive care unit (NICU) treatment period up to 13 weeks

• PDA, treated

  Neonatal intensive care unit (NICU) treatment period up to 13 weeks

Study Arms (2)

Paracetamol

EXPERIMENTAL

Paracetamol 10 mg/mL infusion solution, intravenous loading dose 20 mg/kg, followed by maintenance dose 7.5 mg/kg every 6 h up to 9 days

Drug: Paracetamol 10mg/mL infusion solution

Placebo

PLACEBO COMPARATOR

0.45% sodium chloride (NaCl) solution, equal amounts in mL as would have been given the experimental drug

Other: Placebo

Interventions

Paracetamol 10mg/mL infusion solution DRUG

Intravenous paracetamol solution for infusion

Also known as: acetaminophen, Paracetamol Fresenius Kabi 10 mg/mL infusion solution

Paracetamol

Placebo OTHER

Half physiological saline solution as the non-active placebo solution

Also known as: Natriumklorid Braun 4,5mg/mL solution for infusion

Placebo

Eligibility Criteria

• Age: Up to 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature infants born before 28+0 gestation weeks and/or birth weight less than 1000g

You may not qualify if:

• Severe malformation or suspected chromosomal defect or other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)

Sponsors & Collaborators

• Outi Aikio: lead

Study Sites (1)

Department of Pediatrics, Oulu University Hospital

Oulu, 90014, Finland

Location

Related Publications (4)

• Juujarvi S, Saarela T, Hallman M, Aikio O. Intravenous paracetamol was associated with closure of the ductus arteriosus in extremely premature infants. Acta Paediatr. 2018 Apr;107(4):605-610. doi: 10.1111/apa.14137. Epub 2017 Nov 17.

  PMID: 29105147 BACKGROUND

• Harkin P, Harma A, Aikio O, Valkama M, Leskinen M, Saarela T, Hallman M. Paracetamol Accelerates Closure of the Ductus Arteriosus after Premature Birth: A Randomized Trial. J Pediatr. 2016 Oct;177:72-77.e2. doi: 10.1016/j.jpeds.2016.04.066. Epub 2016 May 20.

  PMID: 27215779 BACKGROUND

• Harma A, Aikio O, Hallman M, Saarela T. Intravenous Paracetamol Decreases Requirements of Morphine in Very Preterm Infants. J Pediatr. 2016 Jan;168:36-40. doi: 10.1016/j.jpeds.2015.08.003. Epub 2015 Aug 29.

  PMID: 26323200 BACKGROUND

• Aikio O, Harkin P, Saarela T, Hallman M. Early paracetamol treatment associated with lowered risk of persistent ductus arteriosus in very preterm infants. J Matern Fetal Neonatal Med. 2014 Aug;27(12):1252-6. doi: 10.3109/14767058.2013.854327. Epub 2013 Oct 31.

  PMID: 24111688 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Ductus Arteriosus, Patent

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Outi Aikio, MD, PhD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Placebo, 0.45 % saline, is similar to paracetamol, both being clear liquids, so the staff will remain unaware which drug the patient receives. The study drug will be kept and prepared away from the NICU, at the separate ward 55 office, in a locked cabinet. The study drug will be prepared by the research nurse, the pharmacist of the ward, or during nighttime, by a nurse who does not participate in the study patients' treatment in any way.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Docent, Specialist in pediatrics and neonatology

Model Details: Randomized, controlled, one center trial

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 21, 2018
• Study Start: September 3, 2018
• Primary Completion: November 3, 2023
• Study Completion: March 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)