Trial Outcomes & Findings for Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants (NCT NCT01860573)

NCT ID: NCT01860573

Last Updated: 2017-04-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 168 participants
• Primary outcome timeframe: 36 weeks post-conceptual age
• Results posted on: 2017-04-10

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	83	85
Overall Study COMPLETED	83	85
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard Amino Acids n=83 Participants 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	High Amino Acids n=85 Participants 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	Total n=168 Participants Total of all reporting groups
Age, Categorical <=18 years	83 Participants n=5 Participants	85 Participants n=7 Participants	168 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	46 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	39 Participants n=7 Participants	85 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 weeks post-conceptual age

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

Outcome measures

Measure	Standard Amino Acids n=67 Participants 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	High Amino Acids n=72 Participants 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
Number of Participants With Weight<10th Percentile for Age	32 Participants	41 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Standard Amino Acids n=60 Participants 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	High Amino Acids n=63 Participants 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
Number of Participants With Length <10th Percentile for Age	29 Participants	42 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Standard Amino Acids n=67 Participants 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	High Amino Acids n=68 Participants 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
Number of Participants With Head Circumference <10th Percentile for Age	20 Participants	23 Participants

PRIMARY outcome

Timeframe: 18-22 months corrected gestational age

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

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.

Outcome measures

Measure	Standard Amino Acids n=59 Participants 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	High Amino Acids n=55 Participants 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
Cognitive Development Score	90.2 units on a scale Standard Deviation 10.3	90.6 units on a scale Standard Deviation 12.7

SECONDARY outcome

Timeframe: Day of life 1, 2, 3, 5 and 7

Outcome measures

Measure	Standard Amino Acids n=83 Participants 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	High Amino Acids n=85 Participants 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
Serum Bicarbonate Day 1	21.2 mmol/L Standard Deviation 2.9	21.8 mmol/L Standard Deviation 2.4
Serum Bicarbonate Day 2	20.7 mmol/L Standard Deviation 3.1	21.2 mmol/L Standard Deviation 3.2
Serum Bicarbonate Day 3	20.0 mmol/L Standard Deviation 3.5	20.1 mmol/L Standard Deviation 3.7
Serum Bicarbonate Day 5	18.7 mmol/L Standard Deviation 4.0	18.0 mmol/L Standard Deviation 4.1
Serum Bicarbonate Day 7	18.7 mmol/L Standard Deviation 4.0	18.3 mmol/L Standard Deviation 4.4

SECONDARY outcome

Timeframe: Day of life 1, 2, 3, 5 and 7

Outcome measures

Measure	Standard Amino Acids n=83 Participants 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	High Amino Acids n=85 Participants 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
Serum Creatinine Day 1	.99 mg/dL Standard Deviation .20	.97 mg/dL Standard Deviation .19
Serum Creatinine Day 2	1.11 mg/dL Standard Deviation .22	1.11 mg/dL Standard Deviation .28
Serum Creatinine Day 3	1.16 mg/dL Standard Deviation .26	1.10 mg/dL Standard Deviation .28
Serum Creatinine Day 5	1.18 mg/dL Standard Deviation .26	1.07 mg/dL Standard Deviation .31
Serum Creatinine Day 7	1.01 mg/dL Standard Deviation .27	.93 mg/dL Standard Deviation .27

SECONDARY outcome

Timeframe: Day of life 1, 2, 3, 5 and 7

Outcome measures

Measure	Standard Amino Acids n=83 Participants 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	High Amino Acids n=85 Participants 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
Serum Blood Urea Nitrogen Day 1	19.0 mg/dL Standard Deviation 7.2	21.6 mg/dL Standard Deviation 8.0
Serum Blood Urea Nitrogen Day 2	26.1 mg/dL Standard Deviation 8.8	35.8 mg/dL Standard Deviation 9.7
Serum Blood Urea Nitrogen Day 3	29.8 mg/dL Standard Deviation 10.6	43.9 mg/dL Standard Deviation 14.3
Serum Blood Urea Nitrogen Day 5	35.3 mg/dL Standard Deviation 15.5	49.1 mg/dL Standard Deviation 17.5
Serum Blood Urea Nitrogen Day 7	32.9 mg/dL Standard Deviation 15.9	38.9 mg/dL Standard Deviation 19.3

Adverse Events

Standard Amino Acids

Serious events: 31 serious events

Other events: 35 other events

Deaths: 0 deaths

High Amino Acids

Serious events: 19 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Amino Acids n=73 participants at risk；n=83 participants at risk 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	High Amino Acids n=74 participants at risk；n=85 participants at risk 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
Pregnancy, puerperium and perinatal conditions Death	12.0% 10/83 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.	10.6% 9/85 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.
Infections and infestations Sepsis	37.3% 31/83 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.	22.4% 19/85 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.
Gastrointestinal disorders Necrotizing Enterocolitis	18.1% 15/83 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.	15.3% 13/85 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.
Nervous system disorders Intaventricular Hemorrhage Grade III/IV	8.4% 7/83 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.	4.7% 4/85 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.
Nervous system disorders Periventricular Leukomalacia	6.0% 5/83 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.	2.4% 2/85 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.

Other adverse events

Measure	Standard Amino Acids n=73 participants at risk；n=83 participants at risk 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	High Amino Acids n=74 participants at risk；n=85 participants at risk 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
Eye disorders Retinopathy of Prematurity	47.9% 35/73 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.	39.2% 29/74 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.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary Dysplasia	43.8% 32/73 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.	43.2% 32/74 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.

Additional Information

Dr. Joseph Bliss

Women & Infants Hospital

Phone: 4012741100

Email: jbliss@wihri.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place