Extreme ImmaturityPhase 4SSALTNCT01795638
Sodium Supplementation and Growth in Very Low Birth Weight Infants
A Phase 4 study testing Sodium chloride in people with Extreme Immaturity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 8 days
- Conditions the study is for
- Extreme Immaturity
- What is being tested?
- Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jan 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 8 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants born at less than 32 weeks postmenstrual age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Impact of Early Postnatal Sodium Supplementation on Weight Gain in Very Low Birth Weight Infants
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.
Read the detailed description
This is a randomized, blinded, placebo-controlled trial in infants born at less than 32 weeks gestation, who are admitted to the Newborn Intensive Care Unit at University of Cincinnati Medical Center, Cincinnati, Ohio. Infants are randomized to receive either 4 meq/kg/day supplemental sodium or an equal amount of sterile water on days of life 7-35. Institutional data from 2008 revealed that a sample size of 56 infants completing the study will detect a 15% difference in the primary outcome of weight gain with 80% power and an alpha error of 0.05. Allowing that 33% drop-out rate (infants may be transferred to another hospital, expire, or be discharged prior to day of life 35), we choose to randomize 75 infants. Calorie intake, serum sodium, weight gain, urine sodium were monitored weekly till 35 days of life or discharge. Infants were assessed for common morbidities associated with prematurity including bronchopulmonary dysplasia, systemic hypertension, late-onset sepsis, necrotizing enterocolitis and retinopathy of prematurity.
- Conditions
- Extreme Immaturity
- Being tested
- Sodium chloride, Placebo
- Keywords
- anthropometrics, weight, nutrition
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chlorideDrug
PlaceboDrug
Also called Sterile Water
sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six weeks of age
Secondary outcomes (9)
Body Length at Six Weeks of Age
The percentage of infants maintaining birth percentile at six weeks between the two study arms will be analyzed
Measured: six weeks of age
Head Circumference
The percentage of infants maintaining birth percentile for head circumference will be compared between the two groups.
Measured: six weeks of age
Mean Systolic Blood Pressure
Systolic blood pressures at 36 weeks post-conceptual age will be compared between the two groups
Measured: 36 weeks post-conceptual age
Chronic Diuretic Therapy
The incidence of chronic diuretic therapy will be compared between the two groups
Measured: patients will be followed during birth hospital stay; an expected average of 3 months of age
Late-onset Sepsis
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.
Measured: patients will be followed during birth hospitalization; an expected average of 3 months of age
Necrotizing Enterocolitis
The incidence of Bell stage II or greater necrotizing enterocolitis after the second week of life will be compared between the two groups
Measured: patients will be followed during birth hospitalization; an expected average of 3 months of age
Chronic Lung Disease
The incidence of chronic lung disease, defined as respiratory support at 36 weeks postmenstrual age will be compared between the two groups
Measured: 36 weeks post-mentrual age
Mortality
The incidence of death during birth hospitalization will be compared between the two study arms
Measured: patients will be followed during birth hospitalization; an expected 3 months of age
Patent Ductus Arteriosus
prolonged Patent Ductus Arteriosus after the second week of life
Measured: After the second week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startOct 2009
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: The unit's standard nutrition practices change which impacted our methodology.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Extreme ImmaturityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Henry T Akinbi, MD, Study director, Cincinnati Childrens Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795638
- Sponsor's protocol ID
- 09-07-28-07
- Acronym
- SSALT
- Status last verified
- Mar 2016
- First submitted
- 13 Feb 2013
- Last updated
- 7 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Postnatal Sodium Supplementation on Weight Gain in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01795638
- Acronym / sponsor ID
- SSALT / 09-07-28-07
- Conditions
- Extreme Immaturity
- Keywords
- anthropometrics, weight, nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The unit's standard nutrition practices change which impacted our methodology.
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- Oct 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Posted 7 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, blinded, placebo-controlled trial in infants born at less than 32 weeks gestation, who are admitted to the Newborn Intensive Care Unit at University of Cincinnati Medical Center, Cincinnati, Ohio. Infants are randomized to receive either 4 meq/kg/day supplemental sodium or an equal amount of sterile water on days of life 7-35. Institutional data from 2008 revealed that a sample size of 56 infants completing the study will detect a 15% difference in the primary outcome of weight gain with 80% power and an alpha error of 0.05. Allowing that 33% drop-out rate (infants may be transferred to another hospital, expire, or be discharged prior to day of life 35), we choose to randomize 75 infants. Calorie intake, serum sodium, weight gain, urine sodium were monitored weekly till 35 days of life or discharge. Infants were assessed for common morbidities associated with prematurity including bronchopulmonary dysplasia, systemic hypertension, late-onset sepsis, necrotizing enterocolitis and retinopathy of prematurity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium chloride | Active comparator | Drug: Sodium chlorideSodium 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. |
| sterile water | Placebo comparator | Drug: PlaceboSterile 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. |
Who may qualify
- Ages
- 7 to 8 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants born at less than 32 weeks postmenstrual age
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium chloride | Drug | Sodium chloride |
| PlaceboAlso: Sterile Watersterile water, 0.4 ml/kg every 6 hours on days of life 7-35. | Drug | sterile water |
Primary outcome
Weight Gain at Six Weeks of Age
Time frame: 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
9 secondary outcomes
Body Length at Six Weeks of Age
Time frame: six weeks of age
Head Circumference
Time frame: six weeks of age
Mean Systolic Blood Pressure
Time frame: 36 weeks post-conceptual age
Chronic Diuretic Therapy
Time frame: patients will be followed during birth hospital stay; an expected average of 3 months of age
Late-onset Sepsis
Time frame: patients will be followed during birth hospitalization; an expected average of 3 months of age
Necrotizing Enterocolitis
Time frame: patients will be followed during birth hospitalization; an expected average of 3 months of age
Chronic Lung Disease
Time frame: 36 weeks post-mentrual age
Mortality
Time frame: patients will be followed during birth hospitalization; an expected 3 months of age
Patent Ductus Arteriosus
Time frame: After the second week of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Extreme Immaturity
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High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
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Active, not recruiting
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
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RecruitingPhase 2
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
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RecruitingPhase 2/3
Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants
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Recruiting
Humidity in Incubators for Tiny Infants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry T Akinbi, MD study director
Cincinnati Childrens Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium chloride in people with Extreme Immaturity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Gain at Six Weeks of Age (time frame: Six weeks of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.