Determination of Lysine Requirement in the Parenterally Fed Neonate

NCT ID: NCT00779753

Last Updated: 2013-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-06-30

Brief Summary

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

Detailed 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.

Conditions

Parenteral Lysine Requirements; Parenteral Feedings

Keywords

Parenteral Feeding; Neonate; Lysine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Neonates

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.

Group Type: EXPERIMENTAL

Amino Acid Solution with different amount of Lysine

Intervention Type: DIETARY_SUPPLEMENT

The infants will be placed on a standard Primene solution for the first 24 hours of the study to obtain baseline values. During the second 24 hours they will receive an amino acid solution that has a different amount of lysine currently found in Primene, all lipid, CHO, minerals, vitamins and trace elements will remain unchanged. The Parenteral lysine will be studied at the following intake levels: 100, 110, 120, 130, 135, 140, 145, 150 , 155, 165, 170, 180, 200, 230, 245, 260mg/kg/d. The minimum energy intake will be 85-90 kcal/kg/day.

Interventions

Amino Acid Solution with different amount of Lysine

The infants will be placed on a standard Primene solution for the first 24 hours of the study to obtain baseline values. During the second 24 hours they will receive an amino acid solution that has a different amount of lysine currently found in Primene, all lipid, CHO, minerals, vitamins and trace elements will remain unchanged. The Parenteral lysine will be studied at the following intake levels: 100, 110, 120, 130, 135, 140, 145, 150 , 155, 165, 170, 180, 200, 230, 245, 260mg/kg/d. The minimum energy intake will be 85-90 kcal/kg/day.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Trophamine; Primene

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Karen Chapman

Clinical Research Nurse Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Chapman, RN, PhD (c)

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto, Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

Chapman KP, Elango R, Ball RO, Pencharz PB. Splanchnic first pass disappearance of threonine and lysine do not differ in healthy men in the fed state. J Nutr. 2013 Mar;143(3):290-4. doi: 10.3945/jn.112.168328. Epub 2013 Jan 16.

Reference Type: DERIVED

PMID: 23325919 (View on PubMed)

Chapman KP, Courtney-Martin G, Moore AM, Langer JC, Tomlinson C, Ball RO, Pencharz PB. Lysine requirement in parenterally fed postsurgical human neonates. Am J Clin Nutr. 2010 Apr;91(4):958-65. doi: 10.3945/ajcn.2009.28729. Epub 2010 Feb 17.

Reference Type: DERIVED

PMID: 20164307 (View on PubMed)

Other Identifiers

0019880597

Identifier Type: -

Identifier Source: org_study_id