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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01860573
Other study ID # 08-0089
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 14, 2013
Last updated April 26, 2016
Start date November 2008
Est. completion date December 2016

Study information

Verified date April 2016
Source Women and Infants Hospital of Rhode Island
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 168
Est. completion date December 2016
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Hours
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Amino acids


Locations

Country Name City State
United States Women & Infants Hospital of Rhode Island Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of weight <10th percentile for age 36 weeks post-conceptual age Yes
Primary Rate of length <10th percentile for age 36 weeks post-conceptual age Yes
Primary Rate of head circumference <10th percentile for age 36 weeks post-conceptual age Yes
Primary Cognitive development score 18-22 months corrected gestational age Yes
Secondary Serum bicarbonate Day of life 1, 2, 3, 5 and 7 Yes
Secondary Serum creatinine Day of life 1, 2, 3, 5 and 7 Yes
Secondary Serum blood urea nitrogen Day of life 1, 2, 3, 5 and 7 Yes
Secondary Serum amino acid profile Day of life 3 and 7 Yes
Secondary Rate of weight <10th percentile for age 18-22 months corrected age Yes
Secondary Rate of length <10th percentile for age 18-22 months corrected age Yes
Secondary Rate of head circumference <10th percentile for age 18-22 months corrected age Yes
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