Trial Outcomes & Findings for Sodium Supplementation and Growth in Very Low Birth Weight Infants (NCT NCT01795638)

NCT ID: NCT01795638

Last Updated: 2020-09-07

Results Overview

Average weight gain in g/kg/day and also as a % birthweight over the first six weeks of the study will be compared between the two study arms

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 53 participants
• Primary outcome timeframe: Six weeks of age
• Results posted on: 2020-09-07

Participant Flow

Participant milestones

Measure	Intervention Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Overall Study STARTED	27	26
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	13	11

Reasons for withdrawal

Measure	Intervention Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Overall Study Death	0	3
Overall Study transferred to quaternary hospital	2	3
Overall Study Protocol Violation	3	0
Overall Study discharged from hospital	7	5
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Sodium Supplementation and Growth in Very Low Birth Weight Infants

Baseline characteristics by cohort

Measure	Sodium Chloride n=27 Participants Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Sterile Water n=26 Participants Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.	Total n=53 Participants Total of all reporting groups
Age, Continuous	28.4 weeks n=5 Participants	29.3 weeks n=7 Participants	28.5 weeks n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Weight at birth in grams	1080 grams n=5 Participants	1021 grams n=7 Participants	1051 grams n=5 Participants
Body length at birth in centimeters	35.8 centimeters n=5 Participants	34.9 centimeters n=7 Participants	35.4 centimeters n=5 Participants
Head circumference at birth in centimeters	25.1 centimeters n=5 Participants	24.6 centimeters n=7 Participants	24.9 centimeters n=5 Participants
Modified CRIB score	1 units on a scale n=5 Participants	2 units on a scale n=7 Participants	1 units on a scale n=5 Participants
Maternal Milk as Primary Diet	17 participants n=5 Participants	14 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Six weeks of age

Average weight gain in g/kg/day and also as a % birthweight over the first six weeks of the study will be compared between the two study arms

Outcome measures

Measure	Intervention n=14 Participants Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo n=15 Participants Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Weight Gain at Six Weeks of Age	26.9 g/kg/day Interval 24.7 to 29.2	22.4 g/kg/day Interval 20.2 to 24.6

SECONDARY outcome

Timeframe: six weeks of age

The percentage of infants maintaining birth percentile at six weeks between the two study arms will be analyzed

Outcome measures

Measure	Intervention n=14 Participants Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo n=15 Participants Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Body Length at Six Weeks of Age	14 percentage	15 percentage

SECONDARY outcome

Timeframe: six weeks of age

The percentage of infants maintaining birth percentile for head circumference will be compared between the two groups.

Outcome measures

Measure	Intervention n=14 Participants Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo n=15 Participants Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Head Circumference	14 percent	15 percent

SECONDARY outcome

Timeframe: 36 weeks post-conceptual age

Systolic blood pressures at 36 weeks post-conceptual age will be compared between the two groups

Outcome measures

Measure	Intervention n=14 Participants Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo n=15 Participants Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Mean Systolic Blood Pressure	84.4 mmHg Interval 74.0 to 96.0	81.8 mmHg Interval 70.0 to 90.0

SECONDARY outcome

Timeframe: patients will be followed during birth hospital stay; an expected average of 3 months of age

The incidence of chronic diuretic therapy will be compared between the two groups

Outcome measures

Measure	Intervention n=14 Participants Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo n=15 Participants Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Chronic Diuretic Therapy	4 participants	3 participants

SECONDARY outcome

Timeframe: patients will be followed during birth hospitalization; an expected average of 3 months of age

The incidence of late-onset sepsis, defined as positive blood culture for credible pathogen and/or 5 days of continuous antimicrobial therapy after the first week of life will be compared between the two groups.

Outcome measures

Measure	Intervention n=27 Participants Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo n=26 Participants Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Late-onset Sepsis	2 participants	12 participants

SECONDARY outcome

Timeframe: patients will be followed during birth hospitalization; an expected average of 3 months of age

The incidence of Bell stage II or greater necrotizing enterocolitis after the second week of life will be compared between the two groups

Outcome measures

Measure	Intervention n=27 Participants Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo n=26 Participants Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Necrotizing Enterocolitis	0 participants	4 participants

SECONDARY outcome

Timeframe: 36 weeks post-mentrual age

The incidence of chronic lung disease, defined as respiratory support at 36 weeks postmenstrual age will be compared between the two groups

Outcome measures

Measure	Intervention n=27 Participants Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo n=26 Participants Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Chronic Lung Disease	9 participants	5 participants

SECONDARY outcome

Timeframe: patients will be followed during birth hospitalization; an expected 3 months of age

The incidence of death during birth hospitalization will be compared between the two study arms

Outcome measures

Measure	Intervention n=27 Participants Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo n=26 Participants Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Mortality	0 participants	4 participants

SECONDARY outcome

Timeframe: After the second week of life

prolonged Patent Ductus Arteriosus after the second week of life

Outcome measures

Measure	Intervention n=27 Participants Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo n=26 Participants Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Patent Ductus Arteriosus	7 participants	9 participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=27 participants at risk Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. Sodium chloride	Placebo n=26 participants at risk Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously. Placebo: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Metabolism and nutrition disorders hypernatremia	11.1% 3/27	0.00% 0/26

Additional Information

Barbara Isemann

University of Cincinnati Medical Center

Phone: 513-584-5060

Email: barbara.isemann@uchealth.com

Results disclosure agreements

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