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Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants

Primary Purpose

Prematurity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Amino acids

About this trial

This is an interventional treatment trial for Prematurity focused on measuring Amino acids, Protein

Eligibility Criteria

undefined - 18 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

birth weight 400 to 1250 grams
24 0/7 to 30 6/7 weeks gestational age

Exclusion Criteria:

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

Sites / Locations

Women & Infants Hospital of Rhode Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard amino acids

High amino acids

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants With Weight<10th Percentile for Age

Number of Participants With Length <10th Percentile for Age

Number of Participants With Head Circumference <10th Percentile for 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.

Secondary Outcome Measures

Serum Bicarbonate

Serum Creatinine

Serum Blood Urea Nitrogen

Full Information

NCT ID

NCT01860573

First Posted

May 14, 2013

Last Updated

February 23, 2017

Sponsor

Women and Infants Hospital of Rhode Island

1. Study Identification

Unique Protocol Identification Number

NCT01860573

Brief Title

Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Women and Infants Hospital of Rhode Island

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prematurity

Keywords

Amino acids, Protein

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard amino acids

Arm Type

Active Comparator

Arm Description

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

Arm Title

High amino acids

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Amino acids

Other Intervention Name(s)

Premasol

Primary Outcome Measure Information:

Title

Number of Participants With Weight<10th Percentile for Age

Time Frame

36 weeks post-conceptual age

Title

Number of Participants With Length <10th Percentile for Age

Time Frame

36 weeks post-conceptual age

Title

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

Time Frame

36 weeks post-conceptual age

Title

Cognitive Development Score

Description

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.

Time Frame

18-22 months corrected gestational age

Secondary Outcome Measure Information:

Title

Serum Bicarbonate

Time Frame

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

Title

Serum Creatinine

Time Frame

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

Title

Serum Blood Urea Nitrogen

Time Frame

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

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: birth weight 400 to 1250 grams 24 0/7 to 30 6/7 weeks gestational age Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph M Bliss, MD, PhD

Organizational Affiliation

Women and Infants Hospital of Rhode Island

Official's Role

Principal Investigator

Facility Information:

Facility Name

Women & Infants Hospital of Rhode Island

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16615955

Citation

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.

Results Reference

background

PubMed Identifier

19403500

Citation

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.

Results Reference

background

PubMed Identifier

12508078

Citation

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.

Results Reference

background

PubMed Identifier

33006765

Citation

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.

Results Reference

derived

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Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants

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