Cysteine requirements for preterm infants

ISRCTN	ISRCTN35832828
DOI	https://doi.org/10.1186/ISRCTN35832828
Protocol serial number	NTR245
Sponsor	Sophia Foundation For Scientific Research (SSWO) (Netherlands)
Funder	Sophia Children's Hospital Fund (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Ms M A Riedijk
Scientific

Erasmus Medical Centre
Sophia Children's Hospital
Department of Neonatology, Room SP3433
P.O. Box 2060
Rotterdam
3000 CB
Netherlands

Phone	+31 (0)10 463 6363
Email	m.riedijk@erasmus.nl

Primary study design	Interventional
Study design	Multicentre, randomised, single blind, active controlled, crossover trial
Secondary study design	Randomised controlled trial
Scientific title	To determine the requirement of cysteine in preterm infants with different gestational ages and post-natal age
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Cystine
Primary outcome measure(s)	1. Fractional oxidation of 13C-phenylalanine 2. Whole body flux of 13C-phenylalanine
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/06/2006

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	80
Key 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
Key exclusion criteria	1. Congenital metabolic disease 2. Congenital anomalies 3. Gastrointestinal diseases
Date of first enrolment	01/11/2004
Date of final enrolment	01/06/2006

Erasmus Medical Centre

Rotterdam
3000 CB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan