Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Control Trial Evaluating the Effect of Two Different Doses of Amino Acids on Growth and Serum Amino Acids in Premature Neonates Admitted to the NICU
Brief Summary: Malnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate that prematurely born neonates commonly develop a severe nutritional deficit during the first weeks after birth, referred to as extrauterine growth restriction. Despite an increase in growth during the second month of hospitalization, many neonates are ultimately discharged home having grown inadequately. The early nutritional deficit affects weight gain as well as growth in length and head circumference.

Growth measurements such as weight, length, and head circumference, however, are macroscopic measures of nutritional status and underestimate the physiologic consequences of prolonged nutritional deprivation. Energy and micronutrient deficiencies alter growth at a cellular and tissue level before macroscopic measures are altered. In the brain, for instance, energy is required for cell division and neuronal growth, glial cell function, and myelination. Energy deprivation may consequently alter neuronal function and growth, resulting in adverse neurodevelopmental outcomes.

Immunocompetence also appears to be sensitive to the untoward effects of energy and nutritional deficiency. Malnourished neonates often exhibit immune deficiencies related to inadequate protein intake that compound an already immature immune system. Such immunodeficiency results in susceptibility to infectious agents that creates substantial morbidity and mortality to the course of intensive care for premature infants.

A recent study suggests that postnatal malnutrition and growth restriction are inevitable if current recommended dietary intakes are followed. Multicenter studies show that variation in dietary intake accounts for 45% of the variation in growth. Hence, efforts have focused on determining whether nutritional deficiency and the observed growth restriction of premature infants can be prevented through the use of more optimal nutritional intake. In addition, inadequate protein support may be a primary cause for growth failure.

Based on animal studies showing high in utero amino acid flux observed during the latter phase of gestation, Thureen et al have suggested the use of higher doses of amino acid supplementation in order to minimize growth restriction and improve outcomes of premature infants. However there are no large human trials that demonstrate that this approach promotes better growth or that it is safe. While small doses of amino acids may be inadequate to promote normal growth, high doses may lead to elevated serum amino acid levels and increase the occurrence of toxicity. Through the implementation of a multicenter, randomized trial and tandem mass spectrometry, the investigators propose to evaluate the effects of two distinct strategies of amino acid supplementation on serum amino acid profiles and growth of premature infants during the first 28 days of life.


Options:
A: Arm Label: Control Study Formula; Type: ACTIVE_COMPARATOR; Interventions: Other: Control Study Formula | Arm Label: Experimental Study Formula; Type: EXPERIMENTAL; Interventions: Other: Experimental Study Formula | Intervention Type: OTHER; Name: Control Study Formula; Assigned to Arm(s): Control Study Formula | Intervention Type: OTHER; Name: Experimental Study Formula; Assigned to Arm(s): Experimental Study Formula
B: Arm Label: Amino acid based infant formula; Type: ACTIVE_COMPARATOR; Interventions: Other: Amino acid based infant formula | Arm Label: Extensively hydrolyzed casein infant formula; Type: EXPERIMENTAL; Interventions: Other: Extensively hydrolyzed casein infant formula | Arm Label: Mother's own breast milk; Type: OTHER; Interventions: Other: Mother's own breast milk | Intervention Type: OTHER; Name: Amino acid based infant formula; Assigned to Arm(s): Amino acid based infant formula | Intervention Type: OTHER; Name: Extensively hydrolyzed casein infant formula; Assigned to Arm(s): Extensively hydrolyzed casein infant formula | Intervention Type: OTHER; Name: Mother's own breast milk; Assigned to Arm(s): Mother's own breast milk
C: Intervention Type: DRUG; Name: Parenteral Nutrition; Assigned to Arm(s): N/A
D: Intervention Type: DRUG; Name: alanine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: amino acids; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: glucagon; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: glucose; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: glutamine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: glycerol; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: insulin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: leucine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: lipids; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: urea; Assigned to Arm(s): N/A

Answer: C