Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05815433
Status:
RECRUITING
Last Update Posted:
2023-07-05
First Post:
2023-03-15
Brief Title:
Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants Exposed to Antibiotics in Labour A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-07
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:
PPDHM
Brief Summary:
The goal of this pilot randomized controlled trial RCT is to examine donor human milk DHM as a clinical intervention targeted at achieving beneficial microbiome signatures in full-term infants who are exposed to intrapartum antibiotic prophylaxis IAP therapy during labour Secondarily this study aims to compare the infant health outcomes of sleep and growth between groups to assess if these outcomes are mediated by infant feeding type or potential differences in microbial signatures Finally this study will compare maternal outcomes of depression anger breastfeeding self-efficacy and breastfeeding rates between groups
The hypothesis of this study is that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following supplementation In addition it is hypothesized that improved homeostasis will promote improved sleep and growth outcomes in participant infants Finally mothers whose infants receive DHM will have lower depression and anger scores and high breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula
The hypothesis of this study is that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following supplementation In addition it is hypothesized that improved homeostasis will promote improved sleep and growth outcomes in participant infants Finally mothers whose infants receive DHM will have lower depression and anger scores and high breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula
Detailed Description:
Investigators propose to conduct a pilot clinical RCT in the postpartum hospital setting examining DHM as an intervention provided to full-term infants who are exposed to Group B Streptococcus GBS antibiotic prophylaxis during labour Randomization of participant infants is currently an ethical practice because DHM supplementation is not standard practice in this population infants receive formula if supplementation of mothers own milk MOM is required Additionally randomization will allow investigators to determine causal relationships between DHM supplementation compared to formula supplementation on the infant gut microbiome Finally conducting research in the clinical setting will allow for pragmatic assessment of DHM as an intervention enhancing external validity and increasing the likelihood of its implementation into healthcare systems to improve healthcare quality
Population The population of interest is vaginally born full-term infants who are exposed to antibiotics in labour through IAP and whose mothers are planning on breastfeeding
Recruitment Mothers greater than 37 weeks gestation admitted to the postpartum unit who test positive for GBS and deliver vaginally will be screened for participation in the study by nurses on the postpartum unit Approximately 20 of all pregnant mothers will test positive for GBS and Alberta Health Services protocol indicates that GBS-positive mothers are given intravenous antibiotics during labour Only mothers who receive the complete Alberta Health Services protocol will qualify for the study Upon recruitment and completion of informed consent infants requiring supplementation of MOM will be randomized to the control or intervention group Investigators will randomize 60 mother-infant dyads providing adequate power to detect overall microbiome differences 30 in each group
Intervention - Donor Human Milk DHM Infants randomized to the intervention group will receive DHM each time supplementation is required for the first 7 days of life The exposure time of 7 days was selected due to feasibility of DHM cost and this is the period when breastfeeding is being established and most formula supplementation occurs Infants in the control group will receive formula when supplementation is required standard care All DHM in North America is pasteurized and provided through certified milk banks regulated by the Human Milk Banking Association of North America and DHM for this study will be obtained from the NorthernStar Mothers Milk Bank NMMB
Data Collection Analysis and Outcomes The primary outcome for this pilot study will result from comparisons of DHM to formula supplementation groups for differences in microbiome signatures such as diversity proportions of Bifidobacteria and proportions of pathogenic organisms Infant stool samples will be collected from soiled diapers at one six and 12 weeks postpartum
Secondary outcomes include infant growth sleep and breastfeeding outcomes that will be collected at one six and 12 weeks postpartum
Population The population of interest is vaginally born full-term infants who are exposed to antibiotics in labour through IAP and whose mothers are planning on breastfeeding
Recruitment Mothers greater than 37 weeks gestation admitted to the postpartum unit who test positive for GBS and deliver vaginally will be screened for participation in the study by nurses on the postpartum unit Approximately 20 of all pregnant mothers will test positive for GBS and Alberta Health Services protocol indicates that GBS-positive mothers are given intravenous antibiotics during labour Only mothers who receive the complete Alberta Health Services protocol will qualify for the study Upon recruitment and completion of informed consent infants requiring supplementation of MOM will be randomized to the control or intervention group Investigators will randomize 60 mother-infant dyads providing adequate power to detect overall microbiome differences 30 in each group
Intervention - Donor Human Milk DHM Infants randomized to the intervention group will receive DHM each time supplementation is required for the first 7 days of life The exposure time of 7 days was selected due to feasibility of DHM cost and this is the period when breastfeeding is being established and most formula supplementation occurs Infants in the control group will receive formula when supplementation is required standard care All DHM in North America is pasteurized and provided through certified milk banks regulated by the Human Milk Banking Association of North America and DHM for this study will be obtained from the NorthernStar Mothers Milk Bank NMMB
Data Collection Analysis and Outcomes The primary outcome for this pilot study will result from comparisons of DHM to formula supplementation groups for differences in microbiome signatures such as diversity proportions of Bifidobacteria and proportions of pathogenic organisms Infant stool samples will be collected from soiled diapers at one six and 12 weeks postpartum
Secondary outcomes include infant growth sleep and breastfeeding outcomes that will be collected at one six and 12 weeks postpartum
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