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 measure
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 infants 4, 6 and 12 months corrected age
7. Cost effectiveness (medical and non-medical) from a societal perspective (Exploratory)
Added 20/09/2017: 8. Gut microbiome characterization (Exploratory
Overall trial start date
14/09/2010
Overall trial end date
17/07/2015
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24884424
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27825008
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29546315