Determination of Lysine Requirement in the Parenterally Fed Neonate

The Hospital for Sick Children

Status: Completed

Conditions: Parenteral Feedings; Parenteral Lysine Requirements

Treatments: Dietary Supplement: Amino Acid Solution with different amount of Lysine

Study type: Interventional

Funder types: Other

Identifiers

NCT00779753

0019880597

Details and patient eligibility

About

The purpose of this study is to establish the parenteral lysine requirements for neonates.

Full description

It is important to identify the appropriate level of lysine requirements for parenterally fed neonates as this amino acid is the limiting amino acid in the diet of neonates. Feeding lysine at requirement improves the likelihood that other amino acids will be utilized appropriately for building proteins. In addition, lysine plays a major role in calcium absorption, development of muscle proteins and in the production of hormones, enzymes and antibodies. We believe that the lysine requirement will be 158 mg/kg/day which is significantly lower than the current 267 and 327 mg/kg/d that is found in the current Trophamine and Primene parenteral solutions.

Enrollment: 6 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically stable neonates on TPN
• minimum of 2.5 g/kg/d protein and 85 - 90 kcal/kg/d)
• Post conception age of ≥ 34 weeks gestation and appropriate for gestational age
• Weight of ≥ 1.5 kg
• NPO or ≤10% of total protein requirement consumed enterally

Exclusion criteria

• Infants on mechanical ventilators, supplemental oxygen or who are receiving medications that would alter protein or energy metabolism (ie. corticosteroid therapy, etc)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Neonates

Experimental group

Description:

Sixteen neonates admitted to the Neonatal Intensive Care Unit (NICU) at the Hospital for Sick Children (SickKids) will be required for this study. The diagnoses will include, but are not limited to, the following: Trachea-esophageal fistula and/or esophageal atresia, Congenital diaphragmatic hernia, imperforate anus, Hirschsprung's disease, Malrotation with or without volvulus, Intestinal atresias, Gastroschisis, Omphalocele, Necrotizing enterocolitis, Respiratory distress syndrome.

Treatment:

Dietary Supplement: Amino Acid Solution with different amount of Lysine