Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315127
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-11-10
Brief Title:
The CanDo Canadian Donor Milk Trial
Sponsor:
Mount Sinai Hospital Canada
Organization:
Mount Sinai Hospital Canada
Study Overview
Official Title:
The CanDo Canadian Donor Milk Trial Pasteurized Human Donor Milk Supplementation in the Well-baby Unit
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn about the impact of donor milk vs formula supplementation on human milk feeding and the health outcomes of infants who require supplementation in well-baby units It aims to explore whether supplementation with donor milk vs formula for infants during the initial hospital stay in a well-baby unit will increase both the exclusivity and duration of breastfeeding at 4 months The Investigators will also explore whether the type of supplementation will positively affect measures of newborns health growth behavior feeding efficacy and parental stress Each participating infant born to a diabetic mother OR born small for hisher gestational age 2500 grams is assigned at random to 2 groups The groups are 1 Donor milk all babies in this group will receive pasteurized donor milk from a trusted milk bank 2 Formula all babies in this group will receive formula as a standard of care
Detailed Description:
Background and Importance Human milk is the ideal nutrition for all infants and research has demonstrated that human donor milk can provide health benefits for preterm infants Approximately 35-50 of late preterm and term infants admitted to a well-baby unit after birth require supplementation due to various reasons including hypoglycemia weight loss or insufficient availability of parents milk However there is limited research to guide decision making on which supplement to prescribe Despite this many hospitals are introducing donor milk in well-baby units in light of the growing recognition of the health protective effects of human milk
Goals Research Aims The primary research aim of this study is to compare the effects of supplementing parents milk with donor milk versus formula in infants at increased risk for supplementation infant born to a mother with diabetes infant with a birth weight smaller than expected for the gestational age SGA on exclusive human milk feeding at 4 months of age Secondary research aims include examining the effects of supplementing parents milk with donor milk on any or exclusive human milk feeding rates at 1 2 and 3 months infant health and growth at hospital discharge and at 1 2 3 and 4 months and breast feeding self-efficacy scores Exploratory outcomes include infant temperament scores at 1 2 3 and 4 months and parental mental health scores at 2 and 4 months using validated questionaires milk cortisol concentrations at 2 and 4 months the use of informally shared milk and the associated financial costs of a donor milk program versus formula
Methods Approaches Expertise This proposed study is a randomized controlled single-center trial that will involve assigning participants to two intervention arms n56 infantsarm The intervention will involve providing donor milk or formula in bottles and will last for the duration of the infants initial hospitalization followed by monthly phone calls and a virtual or in-person assessment at 4 months At each time-point of 1 2 3 and 4-month surveys of breast feeding self-efficacy and health and infant temparement will be conducted and the infants anthropometrics will be measured Additionally measures of parental depression anxiety and stress will be assessed with survey-based tools at 2 and 4 months A coincident human milk sample will be collected at 2 and 4 months and will be analysed for cortisol concentrations The research team has experience running feeding interventions and donor milk trials in newborns and includes experts in nursing medicine dietetics and milk banking
Expected Outcomes This proposed research holds the potential to make a meaningful impact on public health In Canada with approximately 350000 level I nursery admissions each year and high rates of formula supplementation ranging from 35-50 there is a clear opportunity for improvement By promoting exclusive human milk feeding exploring evidence-based practices to inform hospital guidelines and reducing the reliance on informal milk sharing this research aims to enhance the health outcomes for both parents and infants Additionally it seeks to deepen the understanding of early parent-child interactions fostering greater awareness and knowledge in this area
Goals Research Aims The primary research aim of this study is to compare the effects of supplementing parents milk with donor milk versus formula in infants at increased risk for supplementation infant born to a mother with diabetes infant with a birth weight smaller than expected for the gestational age SGA on exclusive human milk feeding at 4 months of age Secondary research aims include examining the effects of supplementing parents milk with donor milk on any or exclusive human milk feeding rates at 1 2 and 3 months infant health and growth at hospital discharge and at 1 2 3 and 4 months and breast feeding self-efficacy scores Exploratory outcomes include infant temperament scores at 1 2 3 and 4 months and parental mental health scores at 2 and 4 months using validated questionaires milk cortisol concentrations at 2 and 4 months the use of informally shared milk and the associated financial costs of a donor milk program versus formula
Methods Approaches Expertise This proposed study is a randomized controlled single-center trial that will involve assigning participants to two intervention arms n56 infantsarm The intervention will involve providing donor milk or formula in bottles and will last for the duration of the infants initial hospitalization followed by monthly phone calls and a virtual or in-person assessment at 4 months At each time-point of 1 2 3 and 4-month surveys of breast feeding self-efficacy and health and infant temparement will be conducted and the infants anthropometrics will be measured Additionally measures of parental depression anxiety and stress will be assessed with survey-based tools at 2 and 4 months A coincident human milk sample will be collected at 2 and 4 months and will be analysed for cortisol concentrations The research team has experience running feeding interventions and donor milk trials in newborns and includes experts in nursing medicine dietetics and milk banking
Expected Outcomes This proposed research holds the potential to make a meaningful impact on public health In Canada with approximately 350000 level I nursery admissions each year and high rates of formula supplementation ranging from 35-50 there is a clear opportunity for improvement By promoting exclusive human milk feeding exploring evidence-based practices to inform hospital guidelines and reducing the reliance on informal milk sharing this research aims to enhance the health outcomes for both parents and infants Additionally it seeks to deepen the understanding of early parent-child interactions fostering greater awareness and knowledge in this area
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None