The effect of paracetamol on breathing of premature infants at birth

Phase 1

• Conditions: Pregnant women expected to deliver between 24 and 30 weeks' gestation; MedDRA version: 20.0Level: LLTClassification code 10033762Term: ParacetamolSystem Organ Class: 100000004848; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2022-003415-29-NL
• Lead Sponsor: eiden University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-06
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- Pregnant women expected to deliver between 24+0-29+6 weeks’ gestation and admitted to the LUMC.
- Informed consent from caregiver(s) (see 10.2).

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Fetuses with congenital anomalies affecting the heart, lungs, kidneys or liver.
- Pregnant women in whom the use of acetaminophen is contraindicated for any reason, consisting of: severe renal impairment, severe hepatic impairment, severe active liver disease (including HELLP-syndrome), a known alcohol addiction and a known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation.
- Pregnant women that use one of the following medication: probenecid, salicylamide, rifampicin, isoniazid, barbiturates, tricyclic antidepressants, anti-epileptic medication, zidovudine, oral coagulants, metoclopramide, domperidone, colestyramine and imatinib.
- Acetaminophen administration required for standard care within 4 hours prior to birth.
- Decision to give palliative care to the neonate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the feasibility of antenatal paracetamol administration to pregnant women 0.5-2 hours prior to birth.;Secondary Objective: The secondary objective of this study is to compare the effect of antenatal acetaminophen administration to standard care on breathing effort, which is expressed as minute volume of spontaneous breathing in the first 1-5 minutes after birth, of premature infants at birth.;Primary end point(s): The primary study outcome is the feasibility, expressed as the success rate, n (%), of pregnant women in the intervention group receiving acetaminophen 0.5-2 hours prior to birth. ;Timepoint(s) of evaluation of this end point: The primary endpoint is evaluated directly after birth.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary study outcome is breathing effort, expressed as average minute volume (mL/kg/min, continuous) in the first 1-5 minutes after birth, calculated using measured tidal volume of spontaneous breaths on CPAP (mL/kg/breath, continuous) and respiratory rate independent of respiratory support (breaths/min, continuous), and assessed by a respiratory function monitor used for respiratory support at birth in the LUMC (Advanced Life Diagnostics, Weener, Germany). .;Timepoint(s) of evaluation of this end point: During the time interval 1-5 minutes after birth.