Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr F W J te Braake

ORCID ID

Contact details

Erasmus Medical Center
Sophia Children's Hospital
Room Sk-2210
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
+31 (0)10 463 6015
f.tebraake@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR243

Study information

Scientific title

Glutathione kinetics and oxidative stress in preterm infants

Acronym

Study hypothesis

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

Received from the local medical ethics committee

Study design

Randomised double-blind active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Glutathione (GSH) deficiency

Intervention

Preterm infants are resuscitated with different oxygen concentrations at birth

Intervention type

Drug

Phase

Not Applicable

Drug names

Glutathione

Primary outcome measures

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 trial start date

11/08/2005

Overall trial end date

11/08/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Known congenital abnormalities
2. Chromosome defects
3. Metabolic disease
4. Endocrine, renal, or hepatic disorder

Recruitment start date

11/08/2005

Recruitment end date

11/08/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3000 CB
Netherlands

Sponsor information

Organisation

Sophia Foundation For Scientific Research (SSWO) (Netherlands)

Sponsor details

P.O. Box 2060
Rotterdam
3000 CB
Netherlands
+31 (0)10 463 6079
info@vriendensophia.nl

Sponsor type

Research organisation

Website

http://www.vriendensophia.nl/?/sophia_home/welkom

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes