Glutathione Metabolism in Neonates

ISRCTN	ISRCTN82896385
DOI	https://doi.org/10.1186/ISRCTN82896385
Secondary identifying numbers	NTR243

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr F W J te Braake
Scientific

Erasmus Medical Center
Sophia Children's Hospital
Room Sk-2210
P.O. Box 2060
Rotterdam
3000 CB
Netherlands

Phone	+31 (0)10 463 6015
Email	f.tebraake@erasmusmc.nl

Study design	Randomised double-blind active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Glutathione kinetics and oxidative stress in preterm infants
Study objectives	1. Low glutathione (GSH) status in preterm and sick term infants is due to a high utilisation rate of GSH rather than a low synthetic capacity 2. Current feeding strategies in preterm and sick term infants fail to supply enough substrate for an adequate GSH production rate
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Glutathione (GSH) deficiency
Intervention	Preterm infants are resuscitated with different oxygen concentrations at birth
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Glutathione
Primary outcome measure	Glutathione synthesis rate, measured at day 2 post-natal
Secondary outcome measures	1. Concentration of oxidative stress markers, Apgar Score, oxygen saturation and heart rate in first 20 minutes after birth, measured on day 1 and day 7 2. Mortality 3. The incidence of bronchopulmonary dysplasia
Overall study start date	11/08/2005
Completion date	11/08/2007

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	80
Total final enrolment	20
Key inclusion criteria	Preterm infants with birth weights less than 1500 g and term infants. Infants in both groups should have arterial catheters for the purpose of obtaining blood samples.
Key exclusion criteria	1. Known congenital abnormalities 2. Chromosome defects 3. Metabolic disease 4. Endocrine, renal, or hepatic disorder
Date of first enrolment	11/08/2005
Date of final enrolment	11/08/2007

Erasmus Medical Center

Rotterdam
3000 CB
Netherlands

Sophia Foundation For Scientific Research (SSWO) (Netherlands)
Research organisation

P.O. Box 2060
Rotterdam
3000 CB
Netherlands

Phone	+31 (0)10 463 6079
Email	info@vriendensophia.nl
Website	http://www.vriendensophia.nl/?/sophia_home/welkom

Charity

Friends of the Sophia Foundation (Stichting Vrienden van het Sophia) (Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2009	18/02/2021	Yes	No

18/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.