Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)
Status:
Recruiting
Trial end date:
2022-09-05
Target enrollment:
Participant gender:
Summary
Birth exposes the newborn to oxidative stress, as due to the switch from a protected,
relatively hypoxic intrauterine milieu into an environment with a high oxygen pressure. The
full-term newborn is well prepared to this massive redox challenge at the time of birth due
to his well-integrated antioxidant defenses. On the contrary, numerous bibliographical data
and our own work demonstrate the fragility of preterm newborns in this context of oxidative
stress, linked to the immaturity of his antioxidant defenses.
Premature birth abruptly propels the fetus from the protected, relatively hypoxic
intrauterine milieu to an environment at risk of free radical injury caused by mechanical
ventilation strategies, including the use of high inspired oxygen fractions or inhaled nitric
oxide, generating excessive reactive oxidative species (ROS). Several studies highlight the
key role of ROS in adverse outcomes of preterm infant suffering from low birth weight,
bronchopulmonary dysplasia, necrotizing enterocolitis or retinopathy.
This project aims to evaluate a therapeutic anti-oxidative strategy in order to correct the
oxidative status of preterm infants. The investigators propose an early intervention that
consists in an antenatal maternal supplementation with N-acetylcysteine (NAC), the acetylated
precursor of both cysteine and glutathione, a key physiological antioxidant. This strategy
could be promising for the development of simplified and personalized care of preterm
infants.
GSH MAP is a randomized, single-blind, placebo-controlled study that aims to determine if NAC
supplementation in women admitted to hospital care due to preterm labor (prior to 34 weeks of
gestational age) may correct glutathione deficiency in neonatal cord blood.