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More amino acids for prevention of extrauterine growth retardation in very low birth weight infants. A randomized controlled trial.

More amino acids for prevention of postnatal growth retardation in very low birth weight infants

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609001058268
Enrollment
60
Registered
2009-12-10
Start date
2009-03-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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 followin

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

Sponsors

Osp. Buon Consiglio
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
1 Hours to 3 Hours
Healthy volunteers
Yes

Inclusion criteria

birth weight < 1500 gr obtaining informed consent from parents

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026