Diaphragmatic Hernia Clinical Trial
— INFORALTHROfficial title:
A Physiological Study to Determine the Enteral Threonine Requirements in Infants Aged 1 to 6 Months
NCT number | NCT02364843 |
Other study ID # | 1000048977 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | October 2023 |
Verified date | April 2024 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is the 5th in a series of physiological studies to determine the amino acid requirements of infants. There have been 4 studies to determine tyrosine, methionine, threonine and lysine requirements in infants when they are fed by parenterally (intravenously). Due to the new requirements of Health Canada for preparation of parenteral solutions, the investigators are starting the phase of the study that determines the enteral (oral) intake of threonine in 1 - 6 mo infants in the interim.
Status | Terminated |
Enrollment | 2 |
Est. completion date | October 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 6 Months |
Eligibility | Inclusion Criteria: - Between ages 1 - 6 months - Born between 32 and 43 weeks gestational age - Clinically stable (normal vital signs and blood values) - Fed by nasogastric (NG), jejunal (J or NJ), or gastric (G) tube Exclusion Criteria: - Infants will be excluded if they are receiving supplemental oxygen - Mechanically ventilated - Have any endocrine or genetic anomalies that affect protein or AA metabolism - On medications that influence protein and AA metabolism (ex: corticosteroid therapy) |
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
Bertolo RF, Chen CZ, Law G, Pencharz PB, Ball RO. Threonine requirement of neonatal piglets receiving total parenteral nutrition is considerably lower than that of piglets receiving an identical diet intragastrically. J Nutr. 1998 Oct;128(10):1752-9. doi: 10.1093/jn/128.10.1752. — View Citation
Chapman KP, Courtney-Martin G, Moore AM, Ball RO, Pencharz PB. Threonine requirement of parenterally fed postsurgical human neonates. Am J Clin Nutr. 2009 Jan;89(1):134-41. doi: 10.3945/ajcn.2008.26654. Epub 2008 Dec 3. — View Citation
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. — View Citation
Courtney-Martin G, Chapman KP, Moore AM, Kim JH, Ball RO, Pencharz PB. Total sulfur amino acid requirement and metabolism in parenterally fed postsurgical human neonates. Am J Clin Nutr. 2008 Jul;88(1):115-24. doi: 10.1093/ajcn/88.1.115. — View Citation
Hogewind-Schoonenboom JE, Huang L, de Groof F, Zhu L, Voortman GJ, Schierbeek H, Vermes A, Chen C, Huang Y, van Goudoever JB. Threonine Requirement of the Enterally Fed Term Infant in the First Month of Life. J Pediatr Gastroenterol Nutr. 2015 Sep;61(3):373-9. doi: 10.1097/MPG.0000000000000807. — View Citation
Huang L, Hogewind-Schoonenboom JE, de Groof F, Twisk JW, Voortman GJ, Dorst K, Schierbeek H, Boehm G, Huang Y, Chen C, van Goudoever JB. Lysine requirement of the enterally fed term infant in the first month of life. Am J Clin Nutr. 2011 Dec;94(6):1496-503. doi: 10.3945/ajcn.111.024166. Epub 2011 Nov 2. — View Citation
Joint WHO/FAO/UNU Expert Consultation. Protein and amino acid requirements in human nutrition. World Health Organ Tech Rep Ser. 2007;(935):1-265, back cover. — View Citation
Kramsch DM, Franzblau C, Hollander W. The protein and lipid composition of arterial elastin and its relationship to lipid accumulation in the atherosclerotic plaque. J Clin Invest. 1971 Aug;50(8):1666-77. doi: 10.1172/JCI106656. — View Citation
Law GK, Bertolo RF, Adjiri-Awere A, Pencharz PB, Ball RO. Adequate oral threonine is critical for mucin production and gut function in neonatal piglets. Am J Physiol Gastrointest Liver Physiol. 2007 May;292(5):G1293-301. doi: 10.1152/ajpgi.00221.2006. Epub 2007 Jan 18. — View Citation
Roberts SA, Ball RO, Moore AM, Filler RM, Pencharz PB. The effect of graded intake of glycyl-L-tyrosine on phenylalanine and tyrosine metabolism in parenterally fed neonates with an estimation of tyrosine requirement. Pediatr Res. 2001 Jan;49(1):111-9. doi: 10.1203/00006450-200101000-00022. — View Citation
Robinson C, Lowe NR, Weatherell JA. Amino acid composition, distribution and origin of "tuft" protein in human and bovine dental enamel. Arch Oral Biol. 1975 Jan;20(1):29-42. doi: 10.1016/0003-9969(75)90149-1. No abstract available. — View Citation
SNYDERMAN SE, NORTON PM, FOWLER DI, HOLT LE Jr. The essential amino acid requirements of infants: lysine. AMA J Dis Child. 1959 Feb;97(2):175-85. doi: 10.1001/archpedi.1959.02070010177004. No abstract available. — View Citation
Zello GA, Pencharz PB, Ball RO. Dietary lysine requirement of young adult males determined by oxidation of L-[1-13C]phenylalanine. Am J Physiol. 1993 Apr;264(4 Pt 1):E677-85. doi: 10.1152/ajpendo.1993.264.4.E677. — View Citation
Zello GA, Wykes LJ, Ball RO, Pencharz PB. Recent advances in methods of assessing dietary amino acid requirements for adult humans. J Nutr. 1995 Dec;125(12):2907-15. doi: 10.1093/jn/125.12.2907. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of increasing threonine intakes on breath F13CO2 in enterally fed infants ages 1 - 6 months | We will be conducting 18 enteral feeding studies using 18 different intakes of threonine and measuring the effects on F13CO2 in breath samples and 13C-Phenylalanine in urine samples | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00966823 -
Fetal Tracheal Balloon Study in Diaphragmatic Hernia
|
Phase 2 | |
Completed |
NCT00371241 -
Antibody Secreting Cell and Cyotokine Profiles in Neonates on ECMO
|
||
Completed |
NCT04716166 -
Incentive Spirometry and Upper Abdominal Laparoscopic Surgery
|
N/A | |
Not yet recruiting |
NCT05354505 -
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
|
N/A | |
Completed |
NCT01240057 -
Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia
|
Phase 2/Phase 3 | |
Completed |
NCT02466451 -
Study in Children With the Diagnosis of Congenital Diaphragmatic Hernia (CDH) and Oesophageal Atresia (EA)
|
N/A | |
Recruiting |
NCT00373438 -
Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia
|
Phase 2 | |
Withdrawn |
NCT00373763 -
Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
|
N/A |