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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard amino acids | Active Comparator | Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day |
|
| High amino acids | Experimental | Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino acids | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Weight<10th Percentile for Age | 36 weeks post-conceptual age | |
| Number of Participants With Length <10th Percentile for Age | 36 weeks post-conceptual age | |
| Number of Participants With Head Circumference <10th Percentile for Age | 36 weeks post-conceptual age | |
| Cognitive Development Score | Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40-160. Higher values indicate a better outcome. | 18-22 months corrected gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Bicarbonate | Day of life 1, 2, 3, 5 and 7 | |
| Serum Creatinine | Day of life 1, 2, 3, 5 and 7 | |
| Serum Blood Urea Nitrogen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph M Bliss, MD, PhD | Women and Infants Hospital of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16615955 | Background | 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. doi: 10.1016/j.jpeds.2005.10.038. | |
| 19403500 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Amino Acids | Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day Amino acids |
| FG001 | High Amino Acids | Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth Amino acids |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Amino Acids | Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day Amino acids |
| BG001 | High Amino Acids | Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth Amino acids |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Weight<10th Percentile for Age | Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age | Posted | Count of Participants | Participants | 36 weeks post-conceptual age |
|
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Participants who died were not able to be assessed for the other (not including serious) adverse events reported, because these adverse events are captured later in hospitalization. Thus, the total infants at risk for other adverse events is fewer than the number at risk for serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Amino Acids | Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day Amino acids |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Pregnancy, puerperium and perinatal conditions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinopathy of Prematurity | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Bliss | Women & Infants Hospital | 4012741100 | jbliss@wihri.org |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000596 | Amino Acids |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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| Day of life 1, 2, 3, 5 and 7 |
| 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. |
| 12508078 | Background | 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. doi: 10.1203/00006450-200301000-00008. |
| 33006765 | Derived | Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Number of Participants With Length <10th Percentile for Age | Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age, and some data were missing. | Posted | Count of Participants | Participants | 36 weeks post-conceptual age |
|
|
|
| Primary | Number of Participants With Head Circumference <10th Percentile for Age | Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age and some data were missing. | Posted | Count of Participants | Participants | 36 weeks post-conceptual age |
|
|
|
| Primary | Cognitive Development Score | Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40-160. Higher values indicate a better outcome. | Data not available for subjects who died or were lost to follow up. | Posted | Mean | Standard Deviation | units on a scale | 18-22 months corrected gestational age |
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|
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| Secondary | Serum Bicarbonate | Posted | Mean | Standard Deviation | mmol/L | Day of life 1, 2, 3, 5 and 7 |
|
|
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| Secondary | Serum Creatinine | Posted | Mean | Standard Deviation | mg/dL | Day of life 1, 2, 3, 5 and 7 |
|
|
|
| Secondary | Serum Blood Urea Nitrogen | Posted | Mean | Standard Deviation | mg/dL | Day of life 1, 2, 3, 5 and 7 |
|
|
|
| 31 |
| 83 |
| 35 |
| 73 |
| EG001 | High Amino Acids | Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth Amino acids | 19 | 85 | 32 | 74 |
| Sepsis | Infections and infestations | Systematic Assessment |
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| Necrotizing Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
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| Intaventricular Hemorrhage Grade III/IV | Nervous system disorders | Systematic Assessment |
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| Periventricular Leukomalacia | Nervous system disorders | Systematic Assessment |
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| Bronchopulmonary Dysplasia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| D000091642 | Urogenital Diseases |
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| Day 7 |
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