Contact information
Type
Scientific
Primary contact
Ms M A Riedijk
ORCID ID
Contact details
Erasmus Medical Centre
Sophia Children's Hospital
Department of Neonatology
Room SP3433
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
+31 (0)10 463 6363
m.riedijk@erasmus.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR245
Study information
Scientific title
To determine the requirement of cysteine in preterm infants with different gestational ages and post-natal age
Acronym
Study hypothesis
1. Cysteine is an essential amino acid for newborn preterm infants
2. Cysteine requirements change rapidly with postnatal age
3. The change in cysteine requirement with age is based upon cystathionase activity
4. Intestinal cystathionase activity is of major importance for the conversion of methionine to cysteine
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised, single blind, active controlled, crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Premature infants, glutathione (GSH) deficiency
Intervention
Infants receive a test diet with graded amounts of cystine for 32 hours.
Intervention type
Drug
Phase
Not Specified
Drug names
Cystine
Primary outcome measures
1. Fractional oxidation of 13C-phenylalanine
2. Whole body flux of 13C-phenylalanine
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/11/2004
Overall trial end date
01/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Infants born with a gestational age of 26 - 29 weeks will be studied at a post-conceptional age of 30 - 32 weeks and at a post-conceptional age of 35 - 37 weeks
2. Infants born at a gestational age of 32 - 34 weeks will also be studied at a post-conceptional age of 35 - 37 weeks
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Congenital metabolic disease
2. Congenital anomalies
3. Gastrointestinal diseases
Recruitment start date
01/11/2004
Recruitment end date
01/06/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
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
Funders
Funder type
Hospital/treatment centre
Funder name
Sophia Children's Hospital Fund (The 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