Condition category
Pregnancy and Childbirth
Date applied
19/04/2007
Date assigned
11/06/2007
Last edited
11/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Isabelle Marc

ORCID ID

Contact details

Hôpital St-François d'Assise-CHUQ
Centre de recherche
10
rue de l'Espinay
Local D6-705
Quebec
G1L 3L5
Canada
+1 418 525 4348
isabelle.marc@crsfa.ulaval.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CAM 06-322

Study information

Scientific title

Acronym

DHA_VPI (DocosaHexaenoic Acid [DHA] for Very Premature Infants)

Study hypothesis

Our hypothesis is that because most Canadians consume a diet poor in oily fish, supplementation with Docosahexaenoic Acid (DHA)-rich algal oil of the Canadian breast-feeding mothers who deliver prematurely is necessary to obtain optimal DHA in breast-milk and to support the nutritional needs of very premature infants, particularly for brain development.

Ethics approval

Approval received from the local ethics committee (Comité d'éthique de la recherche clinique du CHUL, Centre Hospitalier Universitaire de Québec [CHUQ]) in March 2007.

Study design

A randomised, double-blind, placebo-controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Nutrition of very premature infants

Intervention

An appointment will be scheduled for eligible women, where inclusion and exclusion criteria and risks and benefits of the study will be reviewed in detail and an informed consent form will be signed. A fish consumption questionnaire will be completed by the mother to evaluate dietary intake of fish within the last three months.

Up to 72 hours post delivery, consenting eligible women will be stratified and randomised to receive DHA-rich algal oil 500 mg-capsules (containing DHA 200 mg/cap) or placebo (sunflower oil). The experimental product will be the DHA-rich algal oil DHASCO® (Martek Biosciences Corporation, MD, USA). Two capsules will be taken three times per day before meals for a daily intake of 1.2 g DHA. Placebo and experimental capsules will be provided by Martek Biosciences Corporation to cover a period of at least 12-week supplementation. The DHASCO® brand algal oil is high quality product with little or no after-taste. The experimental product will have the same appearance and levels of vitamin E as the placebo.

Mothers will express breast-milk with an electrical pump from both breasts using a sterile glass sucker. The premature infants will be given daily fresh breast-milk as soon as possible. Trophic feeding will be initiated within 24 to 48 hours in stable preterm infants at 1 mL every four hours if birth weight was less than 1000 g or 2 ml every four hours if birth weight was greater than 1000 g. Initial advancement from day three to five will be of 1 ml every two hours and 2 ml every two hours, respectively.

Further progression will aim at the rate of 20 ml/kg/day, according to feeding tolerance. Feeding intolerance will be defined as residuals greater than 50% of previous feeds in two out of three consecutive feeds and/or persistent abdominal distension, vomiting or diarrhoea. Infants who will receive indomethacin or will be clinically unstable may have a delay in the progression of the feeding independent of their feeding tolerance.

e-Baby sampling time:
We extracted some data from six charts of very premature babies randomly selected among those born in the last year at the Mother and Child Centre (Centre Mere-Enfant [CME]) (CHUQ) in order to provide useful information concerning dietary intake in this population, timing (days postpartum) of the first feeding on breast milk, the delay to the full enteral feeding (140 ml/kg), and growth velocity.

Based on these records we decided that the time of sampling would be:
1. Post-natal Day 3: baseline (before the beginning of enteral feeding)
2. Post-natal Day 14: to observe if the DHA level in plasma and erythrocyte of premature infants will be higher in the group whose mothers received DHA supplementation than in the placebo group. This will permit detection of whether DHA supplementation could avoid the decline in plasma and red cell DHA that has previously been reported at Day 14
3. Post-natal Day 49: will be equivalent to 31 to 36 week post conception of the premature infant. A mean of 31 days to reach full enteral feeding (140 ml/kg) noted in our charts is consistent with a recent study. So, Day 49 will be around the 15th day of full enteral feeding

Finally, at Week 37 post-conception, an extra sampling will permit to compare all the premature infants at the same post-conceptional age (fully mature).

Intervention type

Drug

Phase

Not Specified

Drug names

Docosahexaenoic Acid (DHA)-rich algal oil

Primary outcome measures

Fatty acid composition of the red blood cell membranes and plasma phospholipids of infants will be given as % weight of total fatty acids (qualitative) and in mg/dl (quantitative). There are several fatty acids in the omega-3 series, but the primary outcome will be the difference in the DHA in red cell and plasma phospholipids between the two groups at the 49th day postpartum. Blood samples (0.5 ml) will be obtained at the time of sampling for medical need if matching with our post-natal day 3, 14, 49 and post-conceptional week 37.

Secondary outcome measures

Fatty acid composition of mother’s breast-milk will be measured to document the lipid content and the % DHA in the colostrum (at baseline). At the time of the first sampling, mothers will have been nursing for no more than three days. Then every week, sample of breast-milk will be analysed. In order to avoid day-to-day variations, aliquots (0.5 ml) from each daily sample of breast-milk will be pooled weekly, and the combined milk will be analysed to obtain a more representative breast-milk fatty acid profile of the week. Fatty acid composition of mother red cell, taken at the same dates of the premature baby samplings will be related to breast-milk composition.

Overall trial start date

01/06/2007

Overall trial end date

15/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Wowen between 18 and 40 years old
2. Have delivered prematurely (gestional age less than 29 weeks)
3. Plan to breast-feed
4. Signature of consent form for the study

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

25 premature infants per group

Participant exclusion criteria

Mothers will be excluded if at the time of recruitment they have:
1. Regularly consumed more than three servings/wk of fish in the last three months
2. Regularly consumed omega-3 supplements in the last three months
3. Fish allergy
4. Maternal age at time of delivery less than 18 or more than 40 years
5. Haemostatic or coagulation disease or taking anticoagulants (warfarin, heparin), because of risk of interaction with omega-3
6. History of drug or alcohol abuse
7. Unable to stay at Québec city during the baby hospitalisation

Infants will be excluded if they:
1. Are small for gestational age (less than or equal to third percentile)
2. Have a chromosomal abnormality or major congenital malformations (heart excluding ductus arteriosus, atrial septal defect and small ventricular septal defect, brain abnomalities, gastroschisis, omphalocele, diaphragmatic hernia)

Recruitment start date

01/06/2007

Recruitment end date

15/06/2009

Locations

Countries of recruitment

Canada

Trial participating centre

Hôpital St-François d'Assise-CHUQ
Quebec
G1L 3L5
Canada

Sponsor information

Organisation

Foundation of the University Hospital Centre of Quebec (CHUQ) (Canada)

Sponsor details

Hôpital St-François d'Assise
10
de l'Espinay Street
Quebec
G1L 3L5
Canada
danielle.laprise@crsfa.ulaval.ca

Sponsor type

Hospital/treatment centre

Website

http://www.chuq.qc.ca/fr/

Funders

Funder type

Charity

Funder name

SickKids Foundation (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes