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Trial registered on ANZCTR


Registration number
ACTRN12611000419965
Ethics application status
Approved
Date submitted
12/03/2011
Date registered
21/04/2011
Date last updated
21/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early Versus Late Progression of Enteral Feeding in Very Low Birth Weight (VLBW) Infants.
A Randomized, Controlled, Multicenter Trial
Scientific title
Early Versus Late Progression of Enteral Feeding in Very Low Birth Weight (VLBW) Infants.
A Randomized, Controlled, Multicenter Trial
Secondary ID [1] 259773 0
Nil
Universal Trial Number (UTN)
U1111-1119-9168
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition of preterm infants 261355 0
Condition category
Condition code
Diet and Nutrition 259514 259514 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 265664 265664 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
two different feeding'protocols: Infants with birth weight
between 750 and 1500 gr, consecutively admitted to the neonatal intensive care unit of the recruited Institutions were enrolled and randomly assigned to receive an early (Group A, <= 72h of life) or a late (Group B, >= 7
days of life) advancement of enteral feeding volume. A minimal enteral feeding (15 ml/kg/day of preterm formula) was started for all the infants within the first 24 hours of life. Daily advancement of enteral nutrition was <= 20 ml/kg.
Parenteral nutrition was administered until the infant was able to take 120 ml/kg of feeding enterally. this schedule will be applied until discharge the newborn
Intervention code [1] 264207 0
Treatment: Other
Comparator / control treatment
Group B was considered as control group
Control group
Active

Outcomes
Primary outcome [1] 262318 0
time (days) from the start of feeding advancement to reaching full enteral feeds (FEF), consisting in 140 ml/kg/day in very low birth weights infants
Timepoint [1] 262318 0
at one year after randomisation
Secondary outcome [1] 273535 0
time to regain birth weight
Timepoint [1] 273535 0
during the hospitalization

Eligibility
Key inclusion criteria
Infants with birth weight between 750 and 1500 gr, consecutively admitted to the neonatal
intensive care unit of the recruited Institutions
Minimum age
0 Hours
Maximum age
24 Hours
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
major congenital abnormality including known chromosomal abnormality, twin-twin transfusion, significant multi-organ failure prior to trial entry, already received any enteral feeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent researcher uses a computer-generated randomisation table based on blocks to assign infants to treatment A or B within day of life 1 to treatment’s group.
The researcher who carried out the analysis of the data was unaware of the assigned groups
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated randomisation table based on blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/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 outside Australia
Country [1] 3299 0
Italy
State/province [1] 3299 0

Funding & Sponsors
Funding source category [1] 264651 0
Self funded/Unfunded
Name [1] 264651 0
Address [1] 264651 0
Country [1] 264651 0
Primary sponsor type
Hospital
Name
Buon Consiglio Fatebenefratelli Hospital
Address
Via A. Manzoni, 220 Naples
80123
Country
Italy
Secondary sponsor category [1] 263790 0
Hospital
Name [1] 263790 0
Villa Betania Evangelic Hospital
Address [1] 263790 0
Via Argine, Naples
80100
Country [1] 263790 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266646 0
Provincia Romana Fatebenefratelli's bioethical committee
Ethics committee address [1] 266646 0
Via Cassia, Rome 00123
Ethics committee country [1] 266646 0
Italy
Date submitted for ethics approval [1] 266646 0
01/02/2010
Approval date [1] 266646 0
15/03/2010
Ethics approval number [1] 266646 0

Summary
Brief summary
We aim to evaluate the effects of an “early” enteral feeding regimen, compared to one of “late” introduction of enteral feeds, in a group of very low birth weight infants. The timing of introduction and rate of progression of milk feeds is an area of clinical uncertainty with arguments in favour of both early and late introduction of enteral feeds. Early introduction may improve nutrition and growth, but may increase the risk of NEC. Conversely late introduction may be detrimental due to lack of stimulation of the gastrointestinal tract, resulting in villous atrophy and lack of hormone and enzyme production and may not reduce the incidence of NEC. Prolonged use of parenteral nutrition increases the risks of sepsis, cholestatic jaundice and vitamin and mineral deficiencies
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32337 0
Address 32337 0
Country 32337 0
Phone 32337 0
Fax 32337 0
Email 32337 0
Contact person for public queries
Name 15584 0
Gennaro Salvia
Address 15584 0
Via A. Manzoni, 220 Naples 80123
Country 15584 0
Italy
Phone 15584 0
+39815981758
Fax 15584 0
Email 15584 0
salvia@unina.it
Contact person for scientific queries
Name 6512 0
Gennaro Salvia
Address 6512 0
Via A. Manzoni, 220 Naples 80123
Country 6512 0
Italy
Phone 6512 0
+39815981758
Fax 6512 0
Email 6512 0
salvia@unina.it

No information has been provided regarding IPD availability
Summary results
No Results