NCT01860573

Brief Summary

The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

February 1, 2017

Enrollment Period

4.3 years

First QC Date

May 14, 2013

Results QC Date

November 1, 2016

Last Update Submit

February 23, 2017

Conditions

Prematurity

Keywords

Amino acidsProtein

Outcome Measures

Primary Outcomes (4)

  • Number of Participants With Weight<10th Percentile for Age

    36 weeks post-conceptual age

  • Number of Participants With Length <10th Percentile for Age

    36 weeks post-conceptual age

  • Number of Participants With Head Circumference <10th Percentile for Age

    36 weeks post-conceptual age

  • Cognitive Development Score

    Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40-160. Higher values indicate a better outcome.

    18-22 months corrected gestational age

Secondary Outcomes (3)

  • Serum Bicarbonate

    Day of life 1, 2, 3, 5 and 7

  • Serum Creatinine

    Day of life 1, 2, 3, 5 and 7

  • Serum Blood Urea Nitrogen

    Day of life 1, 2, 3, 5 and 7

Study Arms (2)

Standard amino acids

ACTIVE COMPARATOR

Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day

Drug: Amino acids

High amino acids

EXPERIMENTAL

Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth

Drug: Amino acids

Interventions

Amino acidsDRUG
Also known as: Premasol
High amino acidsStandard amino acids

Eligibility Criteria

AgeUp to 18 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • birth weight 400 to 1250 grams
  • /7 to 30 6/7 weeks gestational age

You may not qualify if:

  • chromosomal, structural, metabolic, endocrine, or renal abnormalities that could affect growth
  • infants \>18 hours of age
  • infants in extremis who are unlikely to survive past 72 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (4)

  • Poindexter BB, Langer JC, Dusick AM, Ehrenkranz RA; National Institute of Child Health and Human Development Neonatal Research Network. Early provision of parenteral amino acids in extremely low birth weight infants: relation to growth and neurodevelopmental outcome. J Pediatr. 2006 Mar;148(3):300-305. doi: 10.1016/j.jpeds.2005.10.038.

    PMID: 16615955BACKGROUND

  • Stephens BE, Walden RV, Gargus RA, Tucker R, McKinley L, Mance M, Nye J, Vohr BR. First-week protein and energy intakes are associated with 18-month developmental outcomes in extremely low birth weight infants. Pediatrics. 2009 May;123(5):1337-43. doi: 10.1542/peds.2008-0211.

    PMID: 19403500BACKGROUND

  • Thureen PJ, Melara D, Fennessey PV, Hay WW Jr. Effect of low versus high intravenous amino acid intake on very low birth weight infants in the early neonatal period. Pediatr Res. 2003 Jan;53(1):24-32. doi: 10.1203/00006450-200301000-00008.

    PMID: 12508078BACKGROUND

  • Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

    PMID: 33006765DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. Joseph Bliss
Organization
Women & Infants Hospital
jbliss@wihri.org
4012741100

Study Officials

  • Joseph M Bliss, MD, PhD

    Women and Infants Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Neonatologist

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 22, 2013

Study Start

November 1, 2008

Primary Completion

March 1, 2013

Study Completion

December 1, 2016

Last Updated

April 10, 2017

Results First Posted

April 10, 2017

Record last verified: 2017-02

Locations

US(1)