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Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01860573
Enrollment
168
Registered
2013-05-22
Start date
2008-11-30
Completion date
2016-12-31
Last updated
2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

Keywords

Amino acids, Protein

Brief summary

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.

Interventions

DRUGAmino acids

Sponsors

Women and Infants Hospital of Rhode Island
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Hours
Healthy volunteers
No

Inclusion criteria

* birth weight 400 to 1250 grams * 24 0/7 to 30 6/7 weeks gestational age

Exclusion criteria

* chromosomal, structural, metabolic, endocrine, or renal abnormalities that could affect growth * infants \>18 hours of age * infants in extremis who are unlikely to survive past 72 hours

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Weight<10th Percentile for Age36 weeks post-conceptual age—
Number of Participants With Length <10th Percentile for Age36 weeks post-conceptual age—
Number of Participants With Head Circumference <10th Percentile for Age36 weeks post-conceptual age—
Cognitive Development Score18-22 months corrected gestational ageReported 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.

Secondary

MeasureTime frame
Serum CreatinineDay of life 1, 2, 3, 5 and 7
Serum Blood Urea NitrogenDay of life 1, 2, 3, 5 and 7
Serum BicarbonateDay of life 1, 2, 3, 5 and 7

Countries

United States

Participant flow

Participants by arm

ArmCount
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
83
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
85
Total168

Baseline characteristics

CharacteristicStandard Amino AcidsHigh Amino AcidsTotal
Age, Categorical
<=18 years
83 Participants85 Participants168 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
37 Participants46 Participants83 Participants
Sex: Female, Male
Male
46 Participants39 Participants85 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
35 / 7332 / 74
serious
Total, serious adverse events
31 / 8319 / 85

Outcome results

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.

Time frame: 18-22 months corrected gestational age

Population: Data not available for subjects who died or were lost to follow up.

ArmMeasureValue (MEAN)Dispersion
Standard Amino AcidsCognitive Development Score90.2 units on a scaleStandard Deviation 10.3
High Amino AcidsCognitive Development Score90.6 units on a scaleStandard Deviation 12.7
Primary

Number of Participants With Head Circumference <10th Percentile for Age

Time frame: 36 weeks post-conceptual age

Population: Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age and some data were missing.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard Amino AcidsNumber of Participants With Head Circumference <10th Percentile for Age20 Participants
High Amino AcidsNumber of Participants With Head Circumference <10th Percentile for Age23 Participants
Primary

Number of Participants With Length <10th Percentile for Age

Time frame: 36 weeks post-conceptual age

Population: Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age, and some data were missing.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard Amino AcidsNumber of Participants With Length <10th Percentile for Age29 Participants
High Amino AcidsNumber of Participants With Length <10th Percentile for Age42 Participants
Primary

Number of Participants With Weight<10th Percentile for Age

Time frame: 36 weeks post-conceptual age

Population: Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard Amino AcidsNumber of Participants With Weight<10th Percentile for Age32 Participants
High Amino AcidsNumber of Participants With Weight<10th Percentile for Age41 Participants
Secondary

Serum Bicarbonate

Time frame: Day of life 1, 2, 3, 5 and 7

ArmMeasureGroupValue (MEAN)Dispersion
Standard Amino AcidsSerum BicarbonateDay 220.7 mmol/LStandard Deviation 3.1
Standard Amino AcidsSerum BicarbonateDay 518.7 mmol/LStandard Deviation 4
Standard Amino AcidsSerum BicarbonateDay 320.0 mmol/LStandard Deviation 3.5
Standard Amino AcidsSerum BicarbonateDay 718.7 mmol/LStandard Deviation 4
Standard Amino AcidsSerum BicarbonateDay 121.2 mmol/LStandard Deviation 2.9
High Amino AcidsSerum BicarbonateDay 718.3 mmol/LStandard Deviation 4.4
High Amino AcidsSerum BicarbonateDay 121.8 mmol/LStandard Deviation 2.4
High Amino AcidsSerum BicarbonateDay 221.2 mmol/LStandard Deviation 3.2
High Amino AcidsSerum BicarbonateDay 320.1 mmol/LStandard Deviation 3.7
High Amino AcidsSerum BicarbonateDay 518.0 mmol/LStandard Deviation 4.1
Secondary

Serum Blood Urea Nitrogen

Time frame: Day of life 1, 2, 3, 5 and 7

ArmMeasureGroupValue (MEAN)Dispersion
Standard Amino AcidsSerum Blood Urea NitrogenDay 119.0 mg/dLStandard Deviation 7.2
Standard Amino AcidsSerum Blood Urea NitrogenDay 329.8 mg/dLStandard Deviation 10.6
Standard Amino AcidsSerum Blood Urea NitrogenDay 226.1 mg/dLStandard Deviation 8.8
Standard Amino AcidsSerum Blood Urea NitrogenDay 535.3 mg/dLStandard Deviation 15.5
Standard Amino AcidsSerum Blood Urea NitrogenDay 732.9 mg/dLStandard Deviation 15.9
High Amino AcidsSerum Blood Urea NitrogenDay 549.1 mg/dLStandard Deviation 17.5
High Amino AcidsSerum Blood Urea NitrogenDay 738.9 mg/dLStandard Deviation 19.3
High Amino AcidsSerum Blood Urea NitrogenDay 121.6 mg/dLStandard Deviation 8
High Amino AcidsSerum Blood Urea NitrogenDay 235.8 mg/dLStandard Deviation 9.7
High Amino AcidsSerum Blood Urea NitrogenDay 343.9 mg/dLStandard Deviation 14.3
Secondary

Serum Creatinine

Time frame: Day of life 1, 2, 3, 5 and 7

ArmMeasureGroupValue (MEAN)Dispersion
Standard Amino AcidsSerum CreatinineDay 21.11 mg/dLStandard Deviation 0.22
Standard Amino AcidsSerum CreatinineDay 51.18 mg/dLStandard Deviation 0.26
Standard Amino AcidsSerum CreatinineDay 31.16 mg/dLStandard Deviation 0.26
Standard Amino AcidsSerum CreatinineDay 71.01 mg/dLStandard Deviation 0.27
Standard Amino AcidsSerum CreatinineDay 1.99 mg/dLStandard Deviation 0.2
High Amino AcidsSerum CreatinineDay 7.93 mg/dLStandard Deviation 0.27
High Amino AcidsSerum CreatinineDay 1.97 mg/dLStandard Deviation 0.19
High Amino AcidsSerum CreatinineDay 21.11 mg/dLStandard Deviation 0.28
High Amino AcidsSerum CreatinineDay 31.10 mg/dLStandard Deviation 0.28
High Amino AcidsSerum CreatinineDay 51.07 mg/dLStandard Deviation 0.31

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026