Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula

Prematurity of Fetus Clinical Trial

Official title:

Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300130
• Other study ID #: 45-95
• Status: Completed
• Phase: N/A
• First received: February 18, 2011
• Last updated: February 18, 2011
• Start date: June 1995
• Est. completion date: March 1998

Study information

• Verified date: February 2011
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 1998
• Est. primary completion date: March 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

• preterm birth

• birth weight between 1000 and 2200 g

• more than 80 % of energy intake from infant formula or human milk at enrollment

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prematurity of Fetus

Intervention

Dietary Supplement:
• low docosahexaenoic acid formula

• medium docosahexaenoic acid formula

• high docosahexaenoic acid formula

• breast milk
a non randomized group of breast milk fed infants was included

Locations

Country	Name	City	State
Germany	Children´s Hospital, Zentralklinikum Augsburg	Augsburg
Germany	Josephinum Hospital	Augsburg
Germany	I. Frauenklinik of the Ludwig-Maximilians-University	München
Germany	Lachnerklinik	München
Germany	University Hospital Rechts der Isar	München

Sponsors (4)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	German Federal Ministry of Education and Research, German Research Foundation, Nestlé

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma phospholipid fatty acid composition		28 days after intervention start	No
Primary	visually evoked potentials		48 weeks and 56 weeks postconceptional age	No
Secondary	intensity of endogenous conversion of essential fatty acids into long chain polyunsaturated fatty acids		28 days after study start	No