Premature BirthNCT00196482
Human Milk Fortifiers and Acid-Base Status
A study testing changing of fortifier in people with Premature Birth, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants. Two different compositions are tested, main difference is in electrolyte composiiton. Read more about this study
- Who is it for?
- Ages 10 days to 3 months
- Conditions the study is for
- Premature Birth
- What is being tested?
- changing of fortifier
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2004to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 days to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- growing premature infants with a birth weight < 2000g
Who cannot join
- congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital
Greifswald, M-V, 17485
Christoph Fusch, Prof. Dr.
Jens Rochow, MD
About this study
Official title: Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants
Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.
Two different compositions are tested, main difference is in electrolyte composiiton.
Read the detailed description
Two groups each consisting of 15 infants with a birth weight below 2000g are studied.randomization is startified by three birth weigth classes (<1000g, 1000-1500g,1500 - 2000g) human milk fortifier is introduced in two steps after oral feeding is achieved. two acid-base status and electrolyte concentrations are measured. when metabolic acidosis, defined as BE < -6 mmol/l, occurs fortifier feeding is stopped, and after a wash-out period of three days the alternative product is used.again, occurence of metabolic acidosis, need for oral bicarbonate and effect on longitudinal growth an weight gain are registered.
- Conditions
- Premature Birth
- Being tested
- changing of fortifier
- Keywords
- growth, oral feeding, nutrition
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
changing of fortifierDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of metabolic acidosis
Secondary outcomes (4)
need for oral bicarbonate administartion
longitudinal growth
weight gain
amino acid levels in plasma an urine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany
- Investigators
- Christoph Fusch, Study chair, Department of Neonatology, University Hospital Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196482
- Sponsor's protocol ID
- Fortifier 01
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 12 Sep 2006
- Results posted
- No
Publications
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PubMed 33006765
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants
- ClinicalTrials.gov ID
- NCT00196482
- Acronym / sponsor ID
- Fortifier 01
- Conditions
- Premature Birth
- Keywords
- growth, oral feeding, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- NUMICO,Dr. Heike Mueller, Friedrichsdorf, Germany
- Study start
- Jun 2004
- Study completion
- Feb 2006
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.
Two different compositions are tested, main difference is in electrolyte composiiton.
Detailed description
Two groups each consisting of 15 infants with a birth weight below 2000g are studied.randomization is startified by three birth weigth classes (<1000g, 1000-1500g,1500 - 2000g) human milk fortifier is introduced in two steps after oral feeding is achieved. two acid-base status and electrolyte concentrations are measured. when metabolic acidosis, defined as BE < -6 mmol/l, occurs fortifier feeding is stopped, and after a wash-out period of three days the alternative product is used.again, occurence of metabolic acidosis, need for oral bicarbonate and effect on longitudinal growth an weight gain are registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 10 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- growing premature infants with a birth weight < 2000g
Key exclusion criteria (1 listed)
- congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation
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 |
|---|---|---|
| changing of fortifier | Drug | – |
Primary outcome
frequency of metabolic acidosis
4 secondary outcomes
need for oral bicarbonate administartion
longitudinal growth
weight gain
amino acid levels in plasma an urine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2006.
- Derived from this study: PubMed 33006765Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
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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.
Christoph Fusch study chair
Department of Neonatology, University Hospital Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing changing of fortifier in people with Premature Birth, run by University Medicine Greifswald at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 12 Sep 2006. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Fusch, Professor (+49-3834-86- ext. 6420, fusch@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of metabolic acidosis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00196482, which also lists 1 linked publication.
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 12 Sep 2006.