Sodium Supplementation and Growth in Very Low Birth Weight Infants

NCT01795638 | Terminated Phase 4 Results DMC

• 1 other identifier: 09-07-28-07
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate growth during the neonatal period is critical for optimal long term outcomes. Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total calorie intake are important in ensuring consistent weight gain. Several reports have indicated a positive sodium balance is critical in ensuring good weight gain in very low birth weight infants, however these infants are susceptible to low serum sodium concentrations. Urine sodium values are sometimes used to diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but there is no evidence for this practice in preterm neonates. Our central hypothesis is that early supplementation with sodium will ensure positive sodium balance in very low birth weight infants and will result in optimal weight gain and enhanced long term outcomes. Secondarily we hypothesize that low sodium concentrations in the urine will not correlate with low serum sodium values.

Conditions

Extreme Immaturity

Keywords

anthropometrics; weight; nutrition

Outcome Measures

Primary Outcomes (1)

• Weight Gain at 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

  Six weeks of age

Secondary Outcomes (9)

• Body Length at Six Weeks of Age

  six weeks of age

• Head Circumference

  six weeks of age

• Mean Systolic Blood Pressure

  36 weeks post-conceptual age

• Chronic Diuretic Therapy

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

• Late-onset Sepsis

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

Study Arms (2)

Sodium chloride

ACTIVE COMPARATOR

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.

Drug: Sodium chloride

sterile water

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Sodium chloride DRUG

Sodium chloride

Placebo DRUG

sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.

Also known as: Sterile Water

sterile water

Eligibility Criteria

• Age: 7 Days - 8 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infants born at less than 32 weeks postmenstrual age

You may not qualify if:

• infants with major malformations deemed incompatible with life disease states characterized by edema renal failure, defined as an increase in serum creatinine by 0.5 mg/dl/day or urine output less than 0.5 ml/kg/hour

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• University of Cincinnati: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Body Weight

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Study was terminated after 95% of sample size was recruited. Small number of subjects are analyzed.

Results Point of Contact

• Title: Barbara Isemann
• Organization: University of Cincinnati Medical Center

barbara.isemann@uchealth.com

513-584-5060

Study Officials

• Henry T Akinbi, MD

  Cincinnati Childrens Hospital Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 21, 2013
• Study Start: October 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 7, 2020
• Results First Posted: September 7, 2020

Record last verified: 2016-03

Locations

US (1)