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

eiden University Medical Centre0 个研究点目标入组 40 人开始时间: 2023年1月6日最近更新: 2023年1月9日

试验速览

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•- 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

•- 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.

发起方

eiden University Medical Centre