Randomised controlled trial of acetate in preterm neonates receiving parenteral nutrition

ISRCTN	ISRCTN58031154
DOI	https://doi.org/10.1186/ISRCTN58031154
Protocol serial number	N/A
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive North West (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Steven Ryan
Scientific

Neonatal Unit
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neonatal diseases
Intervention	Standard parenteral nutrition vs novel formulation with replacement of any chloride dose >3 mmol/kg/day as acetate
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/07/1996

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target sample size at registration	30
Key inclusion criteria	Preterm neonates under 32 weeks gestation were entered into the study if they were still receiving intravenous glucose/electrolyte solution on day 3, but not receiving enteral nutrition.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/07/1995
Date of final enrolment	30/07/1996

Neonatal Unit

Liverpool
L8 7SS
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/1997		Yes	No