Bridging the Docosahexaenoic Acid (DHA) Gap: The Effects of Omega-3 Fatty Acid Supplementation in Premature Infants

NCT01908907 | Completed Results DMC

• 1 other identifier: DHA Gap
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand if the "DHA gap" can be corrected by giving a daily dose of DHA oil to preterm babies. DHA is an essential omega-3 fatty acid, which means our body cannot make DHA. We have to take it in through our diet. DHA is important for normal brain and eye health and it may also decrease inflammation. This is important for premature babies because they are at a greater risk for getting diseases related to inflammation, especially in their lungs, eyes and intestines. Since DHA is so important for normal growth, you will find DHA naturally in breast milk and it is now added to infant formula. But the amount in breast milk and infant formula is about half of what your infant should expect to get in the womb (about 13-29mg per day in breast milk vs. 50-75mg per day in the womb). Very premature babies are at an even greater disadvantage because they cannot always eat very much right away and that is the only way they can get essential fatty acids in their body. This means premature babies are getting less DHA than they would in the womb and then the "DHA gap" continues for a longer period of time. This gap also comes at a time when their brain is growing most rapidly and their bodies need it the most. This trial is designed to see if giving DHA, even before the baby can take food orally, will raise his/her DHA blood levels to those of normal term babies.

Conditions

Prematurity

Keywords

Premature Infants; DHA(docosahexaenoic acid); DHA deficit

Outcome Measures

Primary Outcomes (5)

• Days to Reach Full Enteral Feedings and Days on Study Oil.

  This study was designed to determine feasibility and tolerability of enteral DHA supplementation, but was not intended to determine the effects of DHA on health related outcomes. Tolerability was measured by days to reach full enteral feedings, days on study oil, GA at completion of the study and postnatal growth. The days to reach full enteral feedings was defined as enteral intake of 100kcal/kg/d. Safety and tolerability was closely monitored under the oversight of an independent DSMB.

  From enrollment until the infant reaches full feed or is discharged from the NICU, whichever comes first, assessed up to 50 days.

• Feasibility and Tolerability of Daily Enteral DHA Oil - Weight Change

  A linear mixed model was used to explore weight over time.

  30 days from birth

• Long Chain Polyunsaturated Fatty Acid (LCPUFA) Levels - Docosahexaenoic Acid (DHA) Levels in Whole Blood

  Linear mixed models were also used to examine the association between each FA of interest and treatment group over time. Since only three time points were available for FA measurement, only a random intercept was included in the models. For these models, the random effect for multiples was again found to be not needed and removed. Primary outcome variables for this analysis included LNA, ALA, ARA and DHA. Only early/late preterm status was included in the model as a covariate since this was a stratification variable. Continuous dependent variables were transformed using the natural logarithm as needed to meet the assumptions of the regression model (this included LNA and ALA).

  At baseline (enrollment, < 1 week of age), full feedings, discharge

• Feasibility and Tolerability of Daily Enteral DHA Oil - Length Change

  A linear mixed model was used to explore length over time.

  30 days from birth

• Feasibility and Tolerability of Daily Enteral DHA Oil - Head Circumference

  A linear mixed model was used to explore head circumference over time.

  30 days from birth

Secondary Outcomes (1)

• LCPUFA Levels - Arachidonic Acid (ARA) in Whole Blood

  At baseline (enrollment, <1 week of age), full feedings and discharge

Other Outcomes (2)

• LCPUFA Levels - Alpha-linolenic Acid (ALA) in Whole Blood

  Baseline (<1 week of age), full enteral feedings and discharge

• LCPUFA Levels - Linoleic Acid (LNA)

  Baseline, full feedings and discharge

Study Arms (2)

DHA oil

ACTIVE COMPARATOR

DHA oil administered 50 mg/d (0.18ml)as an oil emulsion enterally with feedings or by gavage tube if the infant has one.

Dietary Supplement: DHA oil

(MCT) control oil

PLACEBO COMPARATOR

MCT oil administered 0.18ml as an oil emulsion enterally with feedings or by gavage tube if the infant has one.

Dietary Supplement: (MCT) Control oil

Interventions

DHA oil DIETARY_SUPPLEMENT

Therapy Group:DHA oil administered at 50 mg/d (0.18ml) as an oil emulsion enterally with feedings or by gavage tube if the infant has one.

DHA oil

(MCT) Control oil DIETARY_SUPPLEMENT

Placebo Group:MCT oil administered at 0.18 ml as an oil emulsion enterally with feedings or by gavage tube if the infant has one.

(MCT) control oil

Eligibility Criteria

• Age: 24 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants between 24 and 33 6/7 weeks gestation
• must be less than or equal to 1 week of age

You may not qualify if:

• infants who are considered by the medical team to be non-viable
• infants with multiple or severe congenital anomalies such as gastroschisis, congenital chylothorax or other illnesses that do not allow a feeding tube to be placed or utilized at 7 days of age.
• term infants: who are born to mothers with diabetes or are small for gestational age (SGA-less than the 10th% for adjusted gestational age
• All families consented for this study will need to be able to read and write English
• Mother must be 18 years of age or older
• Taking Omegaven

Sponsors & Collaborators

• Sanford Health: lead
• The Gerber Foundation: collaborator

Study Sites (1)

Sanford Health USD

Sioux Falls, South Dakota, 57117, United States

Location

Related Publications (2)

• Baack ML, Puumala SE, Messier SE, Pritchett DK, Harris WS. Daily Enteral DHA Supplementation Alleviates Deficiency in Premature Infants. Lipids. 2016 Apr;51(4):423-33. doi: 10.1007/s11745-016-4130-4. Epub 2016 Feb 4.

  PMID: 26846324 DERIVED

• Baack ML, Puumala SE, Messier SE, Pritchett DK, Harris WS. What is the relationship between gestational age and docosahexaenoic acid (DHA) and arachidonic acid (ARA) levels? Prostaglandins Leukot Essent Fatty Acids. 2015 Sep;100:5-11. doi: 10.1016/j.plefa.2015.05.003. Epub 2015 Jun 17.

  PMID: 26205427 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Lora Black, Senior Director of Clinical Research
• Organization: Sanford Health

lora.black@sanfordhealth.org

605-328-1368

Study Officials

• Michelle L Baack, MD

  Sanford Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 26, 2013
• Study Start: October 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 21, 2019
• Results First Posted: April 2, 2018

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)