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

Prematurity Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01860573
• Other study ID #: 08-0089
• 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

• Prematurity

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