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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
The Hospital for Sick Children
686 Bay Street
Room 10-9706
Toronto
M5G 0A4
Canada
Phone | +1 (0)416 813 7844 |
---|---|
deborah_l.oconnor@sickkids.ca |
Study information
Study design | Pragmatic multicentre double-blind randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Donor human milk versus preterm formula as a substitute for mothers' own milk for feeding very low birth weight infants |
Study acronym | DoMINO |
Study objectives | 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(s) | Research Ethics Board for The Hospital for Sick Children, ref: 1000017662 |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 14/09/2010 |
Completion date | 17/07/2015 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Neonate |
Sex | Both |
Target number of participants | 352 |
Total final enrolment | 363 |
Key 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 |
Key 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 |
Date of first enrolment | 14/09/2010 |
Date of final enrolment | 19/12/2012 |
Locations
Countries of recruitment
- Canada
Study participating centre
M5G 1X8
Canada
Sponsor information
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 |
---|---|
deborah_l.oconnor@sickkids.ca | |
https://ror.org/057q4rt57 |
Funders
Funder type
Government
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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"