Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001058268
Ethics application status
Approved
Date submitted
4/12/2009
Date registered
10/12/2009
Date last updated
8/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
More amino acids for prevention of extrauterine growth retardation in very low birth weight infants. A randomized controlled trial.
Scientific title
More amino acids for prevention of postnatal growth retardation in very low birth weight infants
Secondary ID [1] 1177 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Growth of very low birth weight infants 252343 0
Condition category
Condition code
Reproductive Health and Childbirth 252534 252534 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
supplementation with essential aminoacids in addition to enteral and parenteral nutrition

The aminoacids administered were the following:
L- Istidina
L- Isoleucina
L- Leucina
L- Lisina
L- Metionina
L- Fenilalanina
L- Treonina
L- Triptofano
L- Valina

The formulation was on opened capsule containing dispersible powder that was added to the milk

The amount of aminoacids provided through enteral and parenteral nutrition, regardless of supplementation with essential amino acids, were the following:

Starting amminoacids intakes: 1.5 gr/kg

Daily increase: 0.5 gr/kg once a day


Total intakes of amminoacids (enteral and parenteral nutrition) nearly to 10 days of life: 3.5-4.0 gr/kg


The essential amminoacids, available as pharmaceutical formulation in capsule form, were delivered with the following schedule, taking into account the weight:

500-1000 gr: 1 gr/kg/once a day
1001-1500 gr: 0.8 gr/kg/once a day
1501 – 2000 gr: 0.5 gr/kg/once a day

Supplementation started on the recruitment, in the first 24 hours of life, and was ceased at discharge
Intervention code [1] 255656 0
Treatment: Drugs
Comparator / control treatment
placebo.

placebo consisted of open capsules, similar to those of the drug, which contained 1 mg of sugar
Control group
Placebo

Outcomes
Primary outcome [1] 253416 0
z-score of weight, height and head circumference.

We measured the deviation of the infant?s growth by reference for weight, length and head circumference. The differences were expressed as z score
Timepoint [1] 253416 0
at discharge from hospital
3, 6, 12 months of post concetional age (corrected age)
Secondary outcome [1] 262524 0
days to regain birth weight (BW), duration of parenteral nutrition (PN), length of hospital stay, incidence of necrotizing enterocolitis (NEC), retinopaty of prematurity (ROP), chronic lung disease (CLD), intraventricular hemorrage (IVH), periventricular leukomalacia (PVL)
Timepoint [1] 262524 0
at discharge from hospital

Eligibility
Key inclusion criteria
birth weight < 1500 gr
obtaining informed consent from parents
Minimum age
1 Hours
Maximum age
3 Hours
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
major congenital abnormality including known
chromosomal abnormality
twin-twin transfusion
intra-uterine transfusion or exchange transfusion
Rhesus iso-immunisation
significant multi-organ failure prior to trial entry

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2352 0
Italy
State/province [1] 2352 0

Funding & Sponsors
Funding source category [1] 256134 0
Self funded/Unfunded
Name [1] 256134 0
Country [1] 256134 0
Italy
Primary sponsor type
Hospital
Name
Osp. Buon Consiglio
Address
Via A. Manzoni, 220 Naples
Country
Italy
Secondary sponsor category [1] 251474 0
None
Name [1] 251474 0
Address [1] 251474 0
Country [1] 251474 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The preterm infant misses the last trimester of fetal nutrient accretion and requirement for immediate nutrient delivery that included amino acids may be essential due to limited glycogen and fat reserves.
Significant nutrient deficiencies are observed in the neonatal intensive care unit
and premature infants are frequently discharged at weights less than the 10th percentile. Perhaps more concerning than low discharge weights is the association of poor growth in the early weeks of hospitalization with abnormal neurodevelopment and an increased prevalence of cerebral palsy. The goal of early
amino-acid supplementation is to provide the preterm infant with intravenous substrate that promotes protein deposition and increased lean body mass that more closely approximates fetal energy production and growth.
Several previous investigations have demonstrated the beneficial effect of early parenteral amino acids on decreasing protein loss in preterm infants
However, despite aggressive nutrition with high intakes of amino acids in the first hours of life, for some essential aminoacids it is impossible to reach in very low birth weight (VLBW) infants levels similar to those observed in human fetus during the second and third trimesters
of pregnancy.
We presumed that the lower concentrations of essential amminoacids limited protein accretion and growing performance of VLBW infants.
We would like to see the effect of administration of essential amino acids on the growth of VLBW infants
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30582 0
Address 30582 0
Country 30582 0
Phone 30582 0
Fax 30582 0
Email 30582 0
Contact person for public queries
Name 13829 0
Gennaro Salvia, MD
Address 13829 0
Via A. Manzoni, 220 Naples
Country 13829 0
Italy
Phone 13829 0
+39813384105391
Fax 13829 0
Email 13829 0
salvia@unina.it
Contact person for scientific queries
Name 4757 0
Gennaro Salvia, MD
Address 4757 0
Via A. Manzoni, 220 Naples
Country 4757 0
Italy
Phone 4757 0
+39813384105391
Fax 4757 0
Email 4757 0
salvia@unina.it

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.