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Trial registered on ANZCTR


Trial ID
ACTRN12612001084875
Ethics application status
Approved
Date submitted
9/10/2012
Date registered
10/10/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The ProVIDe Study. The effect of higher intravenous protein intake for extremely low birthweight babies in the first week after birth on survival free from neurodevelopmental disability at 2 years' corrected age.
Scientific title
For extremely low birthweight babies, does higher intravenous protein intake in the first 5 days after birth improve survival free from neurodevelopmental disability at 2 years' corrected age.
Secondary ID [1] 281361 0
NIL
Universal Trial Number (UTN)
U1111-1135-5325
Trial acronym
PROVIDE: The impact of protein IVN on development
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extremely preterm birth 287583 0
Faltering growth / postnatal growth restriction 287584 0
Neurodevelopmental outcome following preterm birth 287585 0
Condition category
Condition code
Diet and Nutrition 287909 287909 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 287919 287919 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All babies will receive intravenous nutrition according to NICU practices. In addition, babies will be randomised to the intervention or placebo control:

Intervention group: Babies will receive 8.5% intravenous amino acid solution at 0.5 mL/hr via the umbilical arterial catheter (UAC), providing an additional 1 to 2 g/Kg.d protein for 5 days. If the UAC is required for longer than 5 days, the solution will be changed to 0.45% saline.
Intervention code [1] 285822 0
Prevention
Intervention code [2] 285832 0
Treatment: Other
Comparator / control treatment
The UAC solution will be 0.45% saline at 0.5 mL/hr maintained for 5 days.
Control group
Placebo

Outcomes
Primary outcome [1] 288126 0
Survival free from neurodevelopmental disability at 2 years’ corrected age, defined as cerebral palsy, blindness, deafness, developmental delay (defined as a standardised score more than 1 SD below the mean (<-1 SD) on the Bayley Scales of Infant Development Edition 3 [BSID-III] scores), Gross Motor Function Classification System score (Doyle LW: Changing availability of neonatal intensive care for extremely low birthweight infants in Victoria over two decades. Med J Aust 2004, 181(3):136-139).
Timepoint [1] 288126 0
2 years corrected age
Secondary outcome [1] 299460 0
Body composition (the amount and ratio of lean body mass to fat mass) measured by air displacement plethysmography
Timepoint [1] 299460 0
36 weeks corrected gestational age
Secondary outcome [2] 299461 0
Growth velocities for weight, length and head circumference, according to UK WHO growth standards.
Timepoint [2] 299461 0
Birth to 36 weeks corrected gestational age.
Secondary outcome [3] 308194 0
Crown heel length, weight and head circumference and body mass index Z-score change according to UK WHO growth standards.
Timepoint [3] 308194 0
Birth to 36 weeks corrected gestational age.

Eligibility
Key inclusion criteria
Babies <1,000 g at birth and admitted to NICU with a UAC placed.
Minimum age
No limit
Maximum age
24 Hours
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Birth weight greater than or equal to 1000 g; admission to NICU >24 hours after birth; multiple birth >2 children; congenital disorder affecting growth; inborn error of metabolism; in danger of imminent death.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Within 24 hours of birth babies will be randomly allocated to treatment and control groups by central randomisation.

Allocation to intervention or control will be concealed. Allocation to the study will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation Via a web-based interface managed by an independent database controller (IDC). Randomisation will be stratified for recruitment centre, sex and for appropriate-for-gestational-age / small-for-gestational-age status.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11448 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 23464 0
3052 - Parkville
Recruitment outside Australia
Country [1] 4587 0
New Zealand
State/province [1] 4587 0

Funding & Sponsors
Funding source category [1] 289213 0
Charities/Societies/Foundations
Name [1] 289213 0
Nurture Foundation
Address [1] 289213 0
Level 12, ACH Support Building Auckland City Hospital
PO Box 109-167
Newmarket
Auckland 1023
Country [1] 289213 0
New Zealand
Funding source category [2] 289214 0
Other
Name [2] 289214 0
Gravida
Address [2] 289214 0
Liggins Institute
The University of Auckland
Building 505
85 Park Road
Grafton
Auckland 1023
Country [2] 289214 0
New Zealand
Funding source category [3] 289215 0
Charities/Societies/Foundations
Name [3] 289215 0
Cure Kids
Address [3] 289215 0
Laundry Building
Suite 4, Level 4
58 Surrey Cresent
Grey Lynn 1021
Auckland
Country [3] 289215 0
New Zealand
Funding source category [4] 289216 0
Government body
Name [4] 289216 0
Lotteries Health Research
Address [4] 289216 0
The Department of Internal Affairs
46 Waring Taylor Street
WELLINGTON 6011
Country [4] 289216 0
New Zealand
Funding source category [5] 289320 0
Charities/Societies/Foundations
Name [5] 289320 0
A+ Trust
Address [5] 289320 0
Auckland District Health Board Charitable Trust
Private Bag 92024
Auckland 1023
Country [5] 289320 0
New Zealand
Funding source category [6] 300159 0
Government body
Name [6] 300159 0
Health Research Council of New Zealand
Address [6] 300159 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010
Country [6] 300159 0
New Zealand
Primary sponsor type
Individual
Name
Professor Frank Bloomfield
Address
Liggins Institute / Department of Paediatrics
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 284929 0
Individual
Name [1] 284929 0
Professor Caroline Crowther
Address [1] 284929 0
Liggins Institute
University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 284929 0
New Zealand
Other collaborator category [1] 277116 0
Individual
Name [1] 277116 0
Dr Cathryn Conlon
Address [1] 277116 0
Massey University
Institute of Food, Nutrition and Human Health
Private Bag 102 904
North Shore City
Auckland 0745
Country [1] 277116 0
New Zealand
Other collaborator category [2] 277942 0
Individual
Name [2] 277942 0
Professor Jane Harding
Address [2] 277942 0
Liggins Institute / Department of Paediatrics
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [2] 277942 0
New Zealand
Other collaborator category [3] 277943 0
Individual
Name [3] 277943 0
Yannan Jiang
Address [3] 277943 0
Liggins Institute University of Auckland Private Bag 92019 Auckland 1142
Country [3] 277943 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288171 0
Multiregion Ethics committee
Ethics committee address [1] 288171 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 288171 0
New Zealand
Date submitted for ethics approval [1] 288171 0
14/06/2013
Approval date [1] 288171 0
11/07/2013
Ethics approval number [1] 288171 0
No 13/NTB/84

Summary
Brief summary
Postnatal growth restriction, or faltering growth, is almost universal in extremely low birthweight (ELBW) babies. This is largely due to inadequate nutrition, as it is very difficult to maintain nutritional intake in the smallest babies, particularly in the first week after birth. ELBW babies are also at risk of adverse neurodevelopmental outcomes, likely also due, in part, to inadequate nutrition. We have shown that increasing protein intakes in early life prevents faltering growth. We now propose to determine whether increased protein intake in early life in ELBW babies improves neurodevelopmental outcomes through a multicentre, double-blind randomised placebo-controlled trial. The findings of this trial will be of relevance to the management of all preterm babies because the intervention is simple and cheap.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34802 0
Prof Frank Bloomfield
Address 34802 0
Liggins Institute / Department of Paediatrics
University of Auckland
Private Bag 92019
Auckland 1142
Country 34802 0
New Zealand
Phone 34802 0
+64 21 497 598
Fax 34802 0
Email 34802 0
bcormack@adhb.govt.nz
Contact person for public queries
Name 18049 0
Ms Barbara Cormack
Address 18049 0
Neonatal/Paediatric Dietitian
Nutrition Services
Office 2, Level 8. Room 81.038 Support Building, Auckland City Hospital, Private Bag 920 24, Auckland 1142, New Zealand
Country 18049 0
New Zealand
Phone 18049 0
Tel +64 9 307 4949 Ext 23351
Fax 18049 0
Email 18049 0
bcormack@adhb.govt.nz
Contact person for scientific queries
Name 8977 0
Ms Barbara Cormack
Address 8977 0
Neonatal/Paediatric Dietitian
Nutrition Services
Office 2, Level 8. Room 81.038 Support Building, Auckland City Hospital, Private Bag 920 24, Auckland 1142, New Zealand
Country 8977 0
New Zealand
Phone 8977 0
Tel +64 9 307 4949 Ext 23351
Fax 8977 0
Email 8977 0
bcormack@adhb.govt.nz