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Glutathione Metabolism in Neonates.


- candidate number1422
- NTR NumberNTR243
- ISRCTNISRCTN82896385
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR6-sep-2005
- Secondary IDsN/A 
- Public TitleGlutathione Metabolism in Neonates.
- Scientific TitleGlutathione kinetics and oxidative stress in preterm infants.
- ACRONYMN/A
- hypothesisResuscitation after birth with 30% oxygen reduces oxidative stress and is safe in preterm infants.
- Healt Condition(s) or Problem(s) studiedPreterm neonates, Premature infants, Glutathione (GSH) deficiency , Oxidative stress
- Inclusion criteriaPreterm infants with gestational age < 32 weeks.
- Exclusion criteriaKnown congenital abnormalities, chromosome defects, metabolic disease, and endocrine, renal, or hepatic disorder.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-aug-2005
- planned closingdate1-mrt-2012
- Target number of participants200
- InterventionsPreterm infants are resuscitated with different oxygen concentrations at birth.
- Primary outcomeGlutathione synthesis rate.
- Secondary outcome1. Concentration of oxidative stress markers, Apgar Score, oxygen saturation and heart rate in first 20 minutes after birth;
2. Mortality;
3. The incidence of bronchopulmonary dysplasia.
- Timepoints1. Glutathione synthesis: at day 2 postnatal;
2. Concentration of oxidative stress markers on day 1 and day 7;
3. Apgar Score, oxygen saturation and heart rate in first 20 minutes after birth.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD D. Rook
- CONTACT for SCIENTIFIC QUERIESProf. MD. PhD. J.B. Goudoever, van
- Sponsor/Initiator Sophia Foundation For Scientific Research (SSWO)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Vrienden van het Sophia
- PublicationsN/A
- Brief summaryPreterm infants are subjected to increased formation of reactive oxygen species and have reduced antioxidant defenses. The resulting oxidative stress is thought to play an important role in mortality and incidence of neonatal diseases like bronchopulmonary dysplasia. Birth is accompanied by sudden exposure to increased oxygen pressure, which results in increased formation of reactive oxygen species. In term infants, resuscitation at birth with 100% oxygen leads to increased oxidative stress and mortality. Thus, the current recommendations are to start resuscitation of all infants with 21% oxygen. However, it seems that 21% oxygen is not enough for preterm infants. Therefore, we will determine safety, efficacy and oxidative stress of the use of different oxygen concentrations with preterm at birth.
- Main changes (audit trail)
- RECORD6-sep-2005 - 21-okt-2011


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