Donor milk for improved neurodevelopmental outcomes

ISRCTN ISRCTN35317141
DOI https://doi.org/10.1186/ISRCTN35317141
ClinicalTrials.gov number NCT02759809
Secondary identifying numbers MP-102638
Submission date
24/06/2010
Registration date
10/08/2010
Last edited
10/08/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Deborah O'Connor
Scientific

The Hospital for Sick Children
686 Bay Street
Room 10-9706
Toronto
M5G 0A4
Canada

Phone +1 (0)416 813 7844
Email deborah_l.oconnor@sickkids.ca

Study information

Study designPragmatic multicentre double-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleDonor human milk versus preterm formula as a substitute for mothers' own milk for feeding very low birth weight infants
Study acronymDoMINO
Study objectivesOur 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(s)Research Ethics Board for The Hospital for Sick Children, ref: 1000017662
Health condition(s) or problem(s) studiedNeurodevelopmental outcomes
InterventionTreatment 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 typeOther
Primary outcome measureCognitive composite score on the Bayley Scales of Infant and Toddler Development-III (BSID-III) at 18 - 24 months corrected age.
Secondary outcome measures1. 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)
Added 20/09/2017: 8. Gut microbiome characterization (Exploratory
Overall study start date14/09/2010
Completion date17/07/2015

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants352
Total final enrolment363
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment14/09/2010
Date of final enrolment19/12/2012

Locations

Countries of recruitment

  • Canada

Study participating centre

The Hospital for Sick Children
Toronto
M5G 1X8
Canada

Sponsor information

The Hospital for Sick Children
Hospital/treatment centre

Dr. Deborah O’Connor
Physiology and Experimental Medicine
686 Bay Street, room 10-9706
Toronto
M5G 0A4
Canada

Phone +1 (0)416 813 7844
Email deborah_l.oconnor@sickkids.ca
ROR logo "ROR" https://ror.org/057q4rt57

Funders

Funder type

Government

Canadian Institutes of Health Research (CIHR) (Canada) (MP-102638)
Government organisation / National government
Alternative name(s)
Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location
Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 13/05/2014 Yes No
Results article results 08/11/2016 Yes No
Results article results 01/03/2018 Yes No
Results article results 01/12/2019 20/09/2019 Yes No
Results article results 01/02/2020 11/10/2019 Yes No
Results article follow up results 01/02/2020 10/08/2020 Yes No

Editorial Notes

10/08/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The ClinicalTrials.gov number was added.
11/10/2019: Publication reference added.
20/09/2019: Publication reference and total final enrolment added.
19/03/2018: Publication reference added.
20/09/2017: Secondary outcome measures have been updated.
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"