High risk of prematurity: 9g intravenously then 6g (per os) a day until day 7, then 1,8g (per os) a day until 37 weeks of gestational age.
Moderate risk of prematurity: 6g (per os) a day until day 7 then 1,8g ( per os) a day until 37 weeks of gestational age.

Preterm Delivery

N-acetylcysteine

per os: jelly tablets Intravenous Route: Glucidion G5

Placebo

Chu de Nantes

Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)

Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth

The venous umbilical cord blood concentration of glutathione will be measured in red blood cell lysates on C18-reverse phase column using liquid-chromatography combined to mass spectrometry. Homocysteine, cysteine, reduced (GSH) and oxidized (GSSG) glutathione levels will be measured in erythrocytes by comparing an experimental arm versus a placebo arm

The delay time (days) between delivery and inclusion of pregnant women admitted to hospital care due to preterm labor will be compared in an experimental arm versus a placebo arm.

The arterial umbilical cord blood concentration of glutathione will be measured in red blood cell lysates on C18-reverse phase column using liquid-chromatography combined to mass spectrometry. Homocysteine, cysteine, reduced (GSH) and oxidized (GSSG) glutathione levels will be measured in erythrocytes by comparing an experimental arm versus a placebo arm

Changes in glutathione concentration (micromoles/L) in maternal red blood cells will be measured at inclusion and compared in an experimental arm versus a placebo arm. The maternal blood concentration of glutathione will be assessed as in the primary outcome measurement description. Total antioxidant capacity of maternal blood will be measured in plasma using kits such as Trolox Equivalent Antioxidant Capacity (TEAC) assay or lipid-peroxide secretion, measured by TBARS levels, combined to the measurement of levels of oxidized (carbonylated) proteins by mass spectrometry.

Changes in glutathione concentration (micromoles/L) in maternal red blood cells will be measured at delivery and compared in an experimental arm versus a placebo arm. The maternal blood concentration of glutathione will be assessed as in the primary outcome measurement description. Total antioxidant capacity of maternal blood will be measured in plasma using kits such as Trolox Equivalent Antioxidant Capacity (TEAC) assay or lipid-peroxide secretion, measured by TBARS levels, combined to the measurement of levels of oxidized (carbonylated) proteins by mass spectrometry.

Placental gene expression patterns of various enzymes involved in oxidative status such as superoxide dismutase, catalase and glutathione peroxidase and reductase will be measured in an experimental arm versus a placebo arm. Levels of free radical scavengers such as glutathione will be measured using liquid-chromatography combined to mass spectrometry. Placental total antioxidant capacity will be measured using TEAC or TBARS assays, combined to the measurement of levels of oxidized (carbonylated) proteins.

Colostrum or native breastmilk collected at day 7 will serve for determination of glutathione levels and other sulphur amino acids measured using liquid-chromatography combined to mass spectrometry.

Total antioxidant capacity will be measured using TEAC or TBARS assays in combination with mass spectrometry assessment of oxidized (carbonylated) proteins.

Metabolomic, lipidomic and amino acid patterns will be measured in maternal blood at GSH MAP-inclusion and at delivery using liquid-chromatography combined to mass spectrometry. The significance of the impact of NAC supplementation on these patterns will be assessed in link with maternal clinical data.

Weight will be evaluated in the fetus by maternal ultra-sound scans and measured on the newborn at birth and during his hospital stay. The significance of the impact of antenatal NAC supplementation on the anthropometric fetal and newborn data will be assessed taking into account clinical data.

Length will be evaluated in the fetus by maternal ultra-sound scans and measured on the newborn at birth and during his hospital stay. The significance of the impact of antenatal NAC supplementation on the anthropometric fetal and newborn data will be assessed taking into account clinical data.

Head circumference will be evaluated in the fetus by maternal ultra-sound scans and measured on the newborn at birth and during his hospital stay. The significance of the impact of antenatal NAC supplementation on the anthropometric fetal and newborn data will be assessed taking into account clinical data.

Newborn blood currently collected for clinical assessment during hospitalization will be analyzed in order to determine glutathione using liquid-chromatography combined to mass spectrometry. .

Newborn blood total antioxidant capacity will be measured using TEAC or TBARS assays.

Newborn blood currently collected for clinical assessment during hospitalization will be analyzed in order to determine metabolome/lipidome using liquid-chromatography combined to mass spectrometry.

Clinical data in newborn until his discharge and frequency of postnatal pathologies associated with prematurity.

Nantes University Hospital

Light-protection of TPN solutions. TPN bags and infusion sets will be protected from light by aluminum foils throughout the study period.

TPN bags and infusion sets will be exposed to light throughout the study period.

Oxidative Stress in Preterm Infants

TPN bags and infusion sets in the Light-protected group will be covered by aluminum foils to protect the inside TPN solution from exposure to ambient or photo-therapy lights in the NICU. Protection will be made throughout the study period until the infant reaches full feeding and TPN is discontinued.

Light-protection of TPN solutions

Mansoura University Children Hospital

Light Protection of TPN and Oxidative Stress in Preterm Infants

Impact of Protecting TPN Solution From Light on the Oxidant-antioxidant State of Preterm Infant

Measurement of urinary peroxides and serum GSH/GSSG ratio

Death before hospital discharge and/or development of Bronchopulmonary dysplasia defined as oxygen requirement more than 30% fraction of inspired oxygen (FIO2) by 36 weeks corrected gestational age

Necrotizing enterocolitis defined by the modified by Bell's staging criteria

clinical signs of sepsis confirmed by positive blood culture

Pre-threshold and threshold stages of retinopathy of prematurity will be assessed as per our NICU routine by ophthalmology specialist.

Time required to reach full enteral feeding and discontinue TPN

Duration of mechanical ventilation, non-invasive ventilation, and oxygen therapy

Defined as an elevated serum conjugated bilirubin >2 mg/dL (34.2 micromoles/ l)

Episodes of hypoglycemia less than 60 mmol/L, metabolic acidosis with pH less than 7.25 and base deficit more than 10 milliequivalent/L

Duration of admission to the neonatal care unit.

Nehad Nasef

Assistant professor, PhD

saliva for DNA, plasma, red blood cells, urine and tracheal aspirates

Preterm Birth

Bronchopulmonary Dysplasia

Chronic Lung Disease of Prematurity

Jackson Madison County General Hospital

Monroe Carell Jr. Children's Hospital at Vanderbilt

Improving Prematurity-Related Respiratory Outcomes at Vanderbilt

Improving Prematurity-Related Respiratory Outcomes at Vanderbilt: The Prematurity and Respiratory Outcomes Program (PROP)

Need for oxygen, respiratory medications, hospital admissions for respiratory disease or a positive response in at least 1 of 4 morbidity domains during at least 2 separate parental interviews.

bronchopulmonary dysplasia/glutatión

Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)

Light Protection of TPN and Oxidative Stress in Preterm Infants

Improving Prematurity-Related Respiratory Outcomes at Vanderbilt

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