Infant, Low Birth WeightNCT00226187
A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
A study testing Supplement of fatty acid (DHA and AA) in people with Infant, Low Birth Weight, run by University of Oslo at 1 site in Norway.
Trial summary
A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants Background: Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Infant, Low Birth Weight
- What is being tested?
- Supplement of fatty acid (DHA and AA)
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2003to not given
- 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 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight < 1500 g
- Born at one of 4 participating neonatal centers in Norway
Who cannot join
- Cerebral haemorrhage (stage 3 or 4)
- Major congenital malformations that are supposed to affect growth and development
- Illness that require prolonged parenteral nutrition (>4 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants
Background:
Read more
Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Human milk and preterm formulas contain DHA and AA, but at lower concentrations than required to approximate utero accretion rate.
Objective:
To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age.
Design:
A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal centers.
Subjects and methods:
Infants with birth weight < 1.5 kg are randomized to either an intervention or a control group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per 100 ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid, Martek, USA), while the control oil contains vegetable oil without DHA or AA. Blood samples are collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed for fatty acid pattern using high performance liquid chromatography.
- Conditions
- Infant, Low Birth Weight
- Being tested
- Supplement of fatty acid (DHA and AA)
- Keywords
- Fatty acids, Human milk, Infant development, Very low birthweight infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement of fatty acid (DHA and AA)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive development
Secondary outcomes (2)
Growth
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant, Low Birth WeightStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Investigators
- Christian A Drevon, Dr. Med., Study chair, University og Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226187
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2005
- First submitted
- 22 Sep 2005
- Last updated
- 15 Feb 2007
- Results posted
- No
Publications
Almaas AN, Tamnes CK, Nakstad B, Henriksen C, Grydeland H, Walhovd KB, Fjell AM, Iversen PO, Drevon CA. Diffusion tensor imaging and behavior in premature infants at 8 years of age, a randomized controlled trial with long-chain polyunsaturated fatty acids. Early Hum Dev. 2016 Apr;95:41-6. doi: 10.1016/j.earlhumdev.2016.01.021. Epub 2016 Mar 2.
PubMed 26939082Almaas AN, Tamnes CK, Nakstad B, Henriksen C, Walhovd KB, Fjell AM, Due-Tonnessen P, Drevon CA, Iversen PO. Long-chain polyunsaturated fatty acids and cognition in VLBW infants at 8 years: an RCT. Pediatrics. 2015 Jun;135(6):972-80. doi: 10.1542/peds.2014-4094. Epub 2015 May 18.
PubMed 25986018Henriksen C, Haugholt K, Lindgren M, Aurvag AK, Ronnestad A, Gronn M, Solberg R, Moen A, Nakstad B, Berge RK, Smith L, Iversen PO, Drevon CA. Improved cognitive development among preterm infants attributable to early supplementation of human milk with docosahexaenoic acid and arachidonic acid. Pediatrics. 2008 Jun;121(6):1137-45. doi: 10.1542/peds.2007-1511.
PubMed 18519483
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
- ClinicalTrials.gov ID
- NCT00226187
- Acronym / sponsor ID
- 1
- Conditions
- Infant, Low Birth Weight
- Keywords
- Fatty acids, Human milk, Infant development, Very low birthweight infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- Dec 2003
- First posted
- 26 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.
A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants
Background:
Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Human milk and preterm formulas contain DHA and AA, but at lower concentrations than required to approximate utero accretion rate.
Objective:
To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age.
Design:
A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal centers.
Subjects and methods:
Infants with birth weight < 1.5 kg are randomized to either an intervention or a control group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per 100 ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid, Martek, USA), while the control oil contains vegetable oil without DHA or AA. Blood samples are collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed for fatty acid pattern using high performance liquid chromatography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Birth weight < 1500 g
- Born at one of 4 participating neonatal centers in Norway
Key exclusion criteria (3 listed)
- Cerebral haemorrhage (stage 3 or 4)
- Major congenital malformations that are supposed to affect growth and development
- Illness that require prolonged parenteral nutrition (>4 weeks)
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 |
|---|---|---|
| Supplement of fatty acid (DHA and AA) | Procedure or surgery | – |
Primary outcome
Cognitive development
2 secondary outcomes
Growth
Adverse events
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 15 Feb 2007.
- Derived from this study: PubMed 26939082Almaas AN, Tamnes CK, Nakstad B, Henriksen C, Grydeland H, Walhovd KB, Fjell AM, Iversen PO, Drevon CA. Diffusion tensor imaging and behavior in premature infants at 8 years of age, a randomized controlled trial with long-chain polyunsaturated fatty acids. Early Hum Dev. 2016 Apr;95:41-6. doi: 10.1016/j.earlhumdev.2016.01.021. Epub 2016 Mar 2.
- Derived from this study: PubMed 25986018Almaas AN, Tamnes CK, Nakstad B, Henriksen C, Walhovd KB, Fjell AM, Due-Tonnessen P, Drevon CA, Iversen PO. Long-chain polyunsaturated fatty acids and cognition in VLBW infants at 8 years: an RCT. Pediatrics. 2015 Jun;135(6):972-80. doi: 10.1542/peds.2014-4094. Epub 2015 May 18.
- Derived from this study: PubMed 18519483Henriksen C, Haugholt K, Lindgren M, Aurvag AK, Ronnestad A, Gronn M, Solberg R, Moen A, Nakstad B, Berge RK, Smith L, Iversen PO, Drevon CA. Improved cognitive development among preterm infants attributable to early supplementation of human milk with docosahexaenoic acid and arachidonic acid. Pediatrics. 2008 Jun;121(6):1137-45. doi: 10.1542/peds.2007-1511.
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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.
Christian A Drevon, Dr. Med. study chair
University og Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement of fatty acid (DHA and AA) in people with Infant, Low Birth Weight, run by University of Oslo at 1 site in Norway.
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 2 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 15 Feb 2007. 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 Norway. 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?
Cognitive development. 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 NCT00226187, which also lists 3 linked publications.
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 15 Feb 2007.