Condition category
Neonatal Diseases
Date applied
24/06/2010
Date assigned
10/08/2010
Last edited
10/11/2016
Prospective/Retrospective
Prospectively 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 Deborah O'Connor

ORCID ID

Contact details

The Hospital for Sick Children
686 Bay Street
Room 10-9706
Toronto
M5G 0A4
Canada
+1 (0)416 813 7844
deborah_l.oconnor@sickkids.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MP-102638

Study information

Scientific title

Donor human milk versus preterm formula as a substitute for mothers' own milk for feeding very low birth weight infants

Acronym

DoMINO

Study hypothesis

Our primary research hypothesis is that very low birth weight (VLBW) infants fed donor milk as a supplement to mothers' own milk for 90 days or until hospital discharge, whichever comes first, will have an improved cognitive composite score at 18 - 24 months corrected age (CA) compared to infants fed preterm formula as a supplement.

Our secondary hypotheses are that the use of donor milk compared to formula, as a supplement to mothers' own milk, will:
1. Reduce a composite of death, necrotising enterocolitis (NEC), late onset sepsis, chronic lung disease and severe retinopathy of prematurity
2. Support growth
3. To improve language and motor development

Exploratory research questions are will the use of donor milk, as a supplement to mothers' own milk:
1. Influence feeding tolerance and nutrient intake?
2. Have an acceptable cost effectiveness from comprehensive societal perspective?

Ethics approval

Research Ethics Board for The Hospital for Sick Children, ref: 1000017662

Study design

Pragmatic multicentre double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Neurodevelopmental outcomes

Intervention

Treatment Group:
Infants randomised to the intervention group will receive donor milk when mothers' own milk is unavailable. Infants will continue to receive donor milk after transfer to a participating Level II NICU for 90 days after randomisation or discharge home, whichever occurs first.

Control Group:
Infants randomised to the control group will receive formula designed for preterm infants when mothers' own milk is unavailable. Infants will continue to receive formula after transfer to a participating Level II NICU for 90 days after randomization or discharge home, whichever occurs first.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Cognitive composite score on the Bayley Scales of Infant and Toddler Development-III (BSID-III) at 18 - 24 months corrected age.

Secondary outcome measures

1. Morbidity/mortality
2. Composite of death, NEC, late onset sepsis, chronic lung disease or severe retinopathy of prematurity (ROP)
3. Growth (Secondary):
3.1. Weight (g/kg/d), length (mm/wk) and head circumference (mm/wk) gain
3.2. Weight-for-age, length-for-age and head circumference-for-age z-scores
4. Development (Secondary):
4.1. Language and motor composite scores on the BSID-III at 18-24 months corrected age
5. Feeding Tolerance and Nutrient Intake (Exploratory)
5.1. Days to full enteral feeding (150 ml/kg/d)
5.2. Days feedings withheld
5.7. Estimated energy and select nutrient intakes (protein, fat, calcium, phosphorus, iron, zinc)
6. Growth and Breastfeeding (Exploratory)
6.1. Weight-for-age, length-for-age and head circumference-for-age z-scores to 18-24 months corrected age
6.2. Duration (days) of human milk feeding (mothers’ own milk)
6.3. Exclusivity of human milk feeding (mothers’ own milk) at each infant’s 4, 6 and 12 months corrected age
7. Cost effectiveness (medical and non-medical) from a societal perspective (Exploratory)

Overall trial start date

14/09/2010

Overall trial end date

17/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Day 1 to 4 of life
2. Less than 1500 g birth weight
3. Enteral feeding is expected to be initiated in the first 7 days of life

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

352

Participant exclusion criteria

1. Infants with serious congenital or chromosomal anomalies that may contribute to serious developmental outcome
2. Asphyxia (hypoxia or ischaemia) as defined by all of:
2.1. Severe metabolic or mixed acidaemia (pH less than 7.00 or base deficit less than -16) on an umbilical cord arterial blood sample or neonatal blood gas within first hour of life
2.2. Apgar score of 0 - 3 for greater than 5 minutes
2.3. Multi-organ system dysfunction within 72 hours of birth
3. Enrolment in any other clinical study affecting nutritional management during the feeding intervention
4. Reasonable potential that the infant will be transferred to a Neonatal Intensive Care Unit (NICU) or Level II NICU where the study protocol will not be continued

Recruitment start date

14/09/2010

Recruitment end date

19/12/2012

Locations

Countries of recruitment

Canada

Trial participating centre

The Hospital for Sick Children
Toronto
M5G 1X8
Canada

Sponsor information

Organisation

The Hospital for Sick Children

Sponsor details

Dr. Deborah O’Connor
Physiology and Experimental Medicine
686 Bay Street
room 10-9706
Toronto
M5G 0A4
Canada
+1 (0)416 813 7844
deborah_l.oconnor@sickkids.ca

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) (MP-102638)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24884424
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27825008

Publication citations

Additional files

Editorial Notes

10/11/2016: Publication reference added. 31/05/2016: The overall trial end date has been updated from 15/09/2014 to 17/07/2015 and the recruitment end date has been updated from 15/09/2014 to 19/12/2012. 23/05/2016: The third secondary hypothesis (to improve visual, language and motor development) has been edited. Additionally, the following has been removed from the secondary outcome measures: "5. Visual Evoked Potential (Secondary) 5.1. Visual acuity at 4 and 6 months corrected age 5.2. Contrast sensitivity at 4 and 6 months corrected age"