Prematurity of FetusNCT01300130
Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula
A study testing low docosahexaenoic acid formula, medium docosahexaenoic acid formula and high docosahexaenoic acid formula in people with Prematurity of Fetus, run by Ludwig-Maximilians - University of Munich at 5 sites in Germany.
Trial summary
The investigators examined the effect of different levels of docosahexaenoic aicd (a long chain polyunsaturated fatty acid) intake on the fatty acid composition of plasma and erythrocyte phospholipids and on the maturity of visually evoked potentials in preterm infants. Read more about this study
- Who is it for?
- Ages Up to 14 days
- Conditions the study is for
- Prematurity of Fetus
- What is being tested?
- low docosahexaenoic acid formula, medium docosahexaenoic acid formula and high docosahexaenoic acid formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 5 sitesGermany
- Study dates
- Jun 1995to Mar 1998
- 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 Up to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm birth
- birth weight between 1000 and 2200 g
- more than 80 % of energy intake from infant formula or human milk at enrollment
Who cannot join
- apparent genetic, gastrointestinal or metabolic disorders
- artificial ventilation or oxygen supply > 30% at the time of enrollment
- administration of parenteral fat emulsion (> 1 g/kg/day for more than seven days) before or after study entry
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Children´s Hospital, Zentralklinikum Augsburg
Augsburg
Josephinum Hospital
Augsburg
I. Frauenklinik of the Ludwig-Maximilians-University
München
Lachnerklinik
München
University Hospital Rechts der Isar
München
About this study
The investigators examined the effect of different levels of docosahexaenoic aicd (a long chain polyunsaturated fatty acid) intake on the fatty acid composition of plasma and erythrocyte phospholipids and on the maturity of visually evoked potentials in preterm infants. As a secondary outcome the conversion of linoleic acid and alpha linolenic acid into their corresponding long chain polyunsaturated fatty acids was studied.
Preterm infants were randomized in a double-blind fashion to one of three formulas containing different amounts of docosahexaenoic acid during the first two weeks of postnatal life. A control group received human milk. Blood samples were collected at study entry and 14 and 28 days thereafter. Uniformly 13C-labeled linoleic acid and alpha linolenic acid were applied orally before blood sampling at day 28. At postconceptional ages 48 weeks and 56 weeks visually evoked potentials were recorded.
- Conditions
- Prematurity of Fetus
- Being tested
- low docosahexaenoic acid formula, medium docosahexaenoic acid formula, high docosahexaenoic acid formula, breast milk
- Keywords
- neurological development, preterm infants, fatty acid status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low docosahexaenoic acid formulaDietary supplement
medium docosahexaenoic acid formulaDietary supplement
high docosahexaenoic acid formulaDietary supplement
breast milkDietary supplement
a non randomized group of breast milk fed infants was included
| Study group | Role | What they receive |
|---|---|---|
| low docosahexaenoic acid formula | Experimental | Not described Receives: Dietary Supplement: low docosahexaenoic acid formula |
| medium docosahexaenoic acid formula | Experimental | Not described Receives: Dietary Supplement: medium docosahexaenoic acid formula |
| high docosahexaenoic acid formula | Experimental | Not described Receives: Dietary Supplement: high docosahexaenoic acid formula |
| human milk | Active comparator | Not described Receives: Dietary Supplement: breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma phospholipid fatty acid composition
Measured: 28 days after intervention start
visually evoked potentials
Measured: 48 weeks and 56 weeks postconceptional age
Secondary outcomes (1)
intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids
Measured: 28 days after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startJun 1995
- Primary completionMar 1998
- Study completionMar 1998
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 Prematurity of FetusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN), German Federal Ministry of Education and Research, German Research Foundation
- Investigators
- Berthold Koletzko, Prof., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300130
- Sponsor's protocol ID
- 45-95
- Status last verified
- Feb 2011
- First submitted
- 18 Feb 2011
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sauerwald UC, Fink MM, Demmelmair H, Schoenaich PV, Rauh-Pfeiffer AA, Koletzko B. Effect of different levels of docosahexaenoic acid supply on fatty acid status and linoleic and alpha-linolenic acid conversion in preterm infants. J Pediatr Gastroenterol Nutr. 2012 Mar;54(3):353-63. doi: 10.1097/MPG.0b013e31823c3bfd.
PubMed 22008957
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula
- ClinicalTrials.gov ID
- NCT01300130
- Acronym / sponsor ID
- 45-95
- Conditions
- Prematurity of Fetus
- Keywords
- neurological development, preterm infants, fatty acid status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN), German Federal Ministry of Education and Research, German Research Foundation
- Study start
- Jun 1995
- Primary completion
- Mar 1998 (actual)
- Study completion
- Mar 1998 (actual)
- First posted
- 21 Feb 2011 (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.
The investigators examined the effect of different levels of docosahexaenoic aicd (a long chain polyunsaturated fatty acid) intake on the fatty acid composition of plasma and erythrocyte phospholipids and on the maturity of visually evoked potentials in preterm infants. As a secondary outcome the conversion of linoleic acid and alpha linolenic acid into their corresponding long chain polyunsaturated fatty acids was studied.
Preterm infants were randomized in a double-blind fashion to one of three formulas containing different amounts of docosahexaenoic acid during the first two weeks of postnatal life. A control group received human milk. Blood samples were collected at study entry and 14 and 28 days thereafter. Uniformly 13C-labeled linoleic acid and alpha linolenic acid were applied orally before blood sampling at day 28. At postconceptional ages 48 weeks and 56 weeks visually evoked potentials were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low docosahexaenoic acid formula | Experimental | Dietary Supplement: low docosahexaenoic acid formula |
| medium docosahexaenoic acid formula | Experimental | Dietary Supplement: medium docosahexaenoic acid formula |
| high docosahexaenoic acid formula | Experimental | Dietary Supplement: high docosahexaenoic acid formula |
| human milk | Active comparator | Dietary Supplement: breast milk |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- preterm birth
- birth weight between 1000 and 2200 g
- more than 80 % of energy intake from infant formula or human milk at enrollment
Key exclusion criteria (3 listed)
- apparent genetic, gastrointestinal or metabolic disorders
- artificial ventilation or oxygen supply > 30% at the time of enrollment
- administration of parenteral fat emulsion (> 1 g/kg/day for more than seven days) before or after study entry
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 |
|---|---|---|
| low docosahexaenoic acid formula | Dietary supplement | low docosahexaenoic acid formula |
| medium docosahexaenoic acid formula | Dietary supplement | medium docosahexaenoic acid formula |
| high docosahexaenoic acid formula | Dietary supplement | high docosahexaenoic acid formula |
| breast milka non randomized group of breast milk fed infants was included | Dietary supplement | human milk |
Primary outcome
plasma phospholipid fatty acid composition
Time frame: 28 days after intervention start
visually evoked potentials
Time frame: 48 weeks and 56 weeks postconceptional age
1 secondary outcome
intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids
Time frame: 28 days after study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
- Derived from this study: PubMed 22008957Sauerwald UC, Fink MM, Demmelmair H, Schoenaich PV, Rauh-Pfeiffer AA, Koletzko B. Effect of different levels of docosahexaenoic acid supply on fatty acid status and linoleic and alpha-linolenic acid conversion in preterm infants. J Pediatr Gastroenterol Nutr. 2012 Mar;54(3):353-63. doi: 10.1097/MPG.0b013e31823c3bfd.
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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.
Berthold Koletzko, Prof. principal investigator
Ludwig-Maximilians - University of Munich
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low docosahexaenoic acid formula, medium docosahexaenoic acid formula and high docosahexaenoic acid formula in people with Prematurity of Fetus, run by Ludwig-Maximilians - University of Munich at 5 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
plasma phospholipid fatty acid composition (time frame: 28 days after intervention start). The study lists 2 primary outcomes in all. 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 NCT01300130, 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 21 Feb 2011.