Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL159280 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
This study is being conducted to determine the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health and nutrition/breastfeeding, among children with sickle cell disease, and behavioral interventions aimed to reshape psychological resilience and lifestyle factors towards positive health outcomes.
During year 3 of the award period, 20 mother-infant dyads will be randomly assigned to either a community-based breastfeeding support group or observation. Acceptability to enrollment, intervention adherence for at least 6 months and preliminary effectiveness will be captured. Biomarkers of inflammation, development of asthma and incidences of pain and/or acute chest syndrome will be compared among the intervention and control groups.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastfeeding Intervention Group | Experimental | Ten mother-infant dyads will be recruited to a six-month, community-based intervention aimed to promote sustained breastfeeding for at least six months among mothers of infants with sickle cell disease. The intervention will include an online, social media-based support group, online educational modules, monthly in-person educational sessions, access to free breast pump rentals, and monthly peer-led home visits by certified Vanderbilt-affiliated Maternal Infant Health Outreach Specialists. We obtain whole blood specimens for analysis of oxidative stress and inflammation at 3, 6, 12 and 24 months. |
|
| Observation Group | Other | A 24 month observation of 10 mother-infant dyads affected by sickle cell disease that initiate breastfeeding. These dyads will observed for breastfeeding exclusivity/dosage and duration. We obtain whole blood specimens for analysis of oxidative stress and inflammation at 3, 6, 12 and 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breastfeeding support group | Behavioral | community-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention | acceptance (number of mothers enrolled/number of mothers approached) and retention (number of mothers to complete 6 month support group intervention/number enrolled) | 6 months |
| Preliminary Effectiveness | Percentage of mothers of infants with sickle cell disease that successful complete 6 months of breastfeeding, comparing the intervention vs. control groups | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma | Prevalence of asthma among children with sickle cell disease that were breastfed compared to those that were not | 4 year follow up period |
| Acute chest syndrome | Incidence rate of episodes of acute chest syndrome among children with sickle cell disease that were vs. were not breastfed |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brandi M Pernell, DNP, MSPH | Contact | 2058640238 | brandimcclain@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brandi M Pernell, DNP, MSPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
I will share by IPD. I do not have a URL at this time and could not get my application to submit without submitting a URL
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided
Randomized control trial
Not provided
Not provided
Not provided
Not provided
| Observation | Other | Observe prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease |
|
| 4 year follow up period |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005247 | Feeding Behavior |
| D001519 | Behavior |