ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

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]

at discharge from hospital
3, 6, 12 months of post concetional age (corrected age)

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Italy

Primary sponsor type

Hospital

Name

Osp. Buon Consiglio

Address

Via A. Manzoni, 220 Naples

Country

Italy

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Gennaro Salvia, MD

Address

Via A. Manzoni, 220 Naples

Country

Italy

Phone

+39813384105391

Fax

salvia@unina.it

Contact person for scientific queries

Name

Gennaro Salvia, MD

Address

Via A. Manzoni, 220 Naples

Country

Italy

Phone

+39813384105391

Fax

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically