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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53465

Enrollment

Registered

2022-12-15

Start date

2023-09-26

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatale transitie, ademhaling bij geboorte Prematurity preterm birth

Interventions

The intervention comprises administration of 1000 mg paracetamol 0.5-2 hours prior to expected birth. The control group receives placebo with 0.9% NaCl concentrate (physiological saline).

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The primary study outcome is the feasibility, expressed as the success rate, n (%), of pregnant women in the study receiving acetaminophen/placebo 0.5-2 hours prior to birth. Non-success are noted when pregnant women; - deliver after 31 weeks* gestation, but have already received study medication; - require more than 3 dosages of study medication; - withdraw their consent after receiving study medication and before delivery.	—

Measure

Time frame

The primary study outcome is the feasibility, expressed as the success rate, n (%), of pregnant women in the study receiving acetaminophen/placebo 0.5-2 hours prior to birth. Non-success are noted when pregnant women; - deliver after 31 weeks* gestation, but have already received study medication; - require more than 3 dosages of study medication; - withdraw their consent after receiving study medication and before delivery.

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Secondary

Measure	Time frame
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). .	—

Measure

Time frame

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). .

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)