The effect of antenatal acetaminophen administration on breathing effort of premature infants at birth: a pilot study

Phase 4

Recruiting

Conditions: Perinatale transitie, ademhaling bij geboorte
Prematurity
preterm birth

Registration Number: NL-OMON53465

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- Pregnant women expected to deliver between 24+0-29+6 weeks* gestation and
admitted to the Leiden University Medical Centre (LUMC).
- Informed consent from caregiver(s)

Exclusion Criteria

- Fetuses with congenital anomalies affecting the heart, lungs, kidneys or
liver.
- Pregnant women in whom the use of paracetamol 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study outcome is the feasibility, expressed as the success rate, n<br /><br>(%), of pregnant women in the study receiving acetaminophen/placebo 0.5-2 hours<br /><br>prior to birth.<br /><br>Non-success are noted when pregnant women;<br /><br>- deliver after 30 weeks* gestation, but have already received study<br /><br>medication;<br /><br>- require more than 3 dosages of study medication;<br /><br>- withdraw their consent after receiving study medication and before delivery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study outcome is breathing effort, expressed as average minute<br /><br>volume (mL/kg/min, continuous) in the first 1-5 minutes after birth, calculated<br /><br>using measured tidal volume of spontaneous breaths on CPAP (mL/kg/breath,<br /><br>continuous) and respiratory rate independent of respiratory support<br /><br>(breaths/min, continuous), and assessed by a respiratory function monitor used<br /><br>for respiratory support at birth in the LUMC (Advanced Life Diagnostics,<br /><br>Weener, Germany). .</p><br>