Condition category
Neonatal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
04/11/2008
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

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

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

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

Publication citations

Additional files

Editorial Notes