Clinical trials: Lactation
Breastfeeding, Exclusive, Pain, Acute
Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study
Every year, 1 million women cease breastfeeding (BF) before 6 months, the minimum time required for optimal maternal and infant health, development, and well-being.
- Conditions
- Breastfeeding, Exclusive, Pain, Acute, Maternal Distress, Parent-Child Relations
- Trial name
- PROMPT (NCT05262920)
- Testing
- The BSM Intervention, Attention Control
- Where
- 2 sites in United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- University of Connecticut
Multiple Sclerosis, Clinically Isolated Syndrome
A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] treated with…
- Trial name
- SOPRANINO (NCT04998851)
- Testing
- Ocrelizumab
- Where
- 8 sites in United States, Spain and 1 more
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
Malnutrition, Wasting
Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children
Studies to date on the effects of Moringa oleifera in diabetes and anemia and animal studies that examine the utility of moringa for increased milk and litter yield are of small scale, however high-quality large-scale placebo or…
- Conditions
- Malnutrition, Wasting, Growth Failure
- Trial name
- NCT04587271
- Testing
- Moringa oleifera (high dose), Moringa oleifera (low dose)
- Where
- 2 sites in Kenya
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Suzanna L Attia
Chronic Hypertension in Pregnancy
Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
This is a phase IV prospective trial to collect and analyze information about the maternal pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum lactation.
- Trial name
- NCT02353806
- Testing
- Amlodipine besylate
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Texas Southwestern Medical Center
Diarrhea
PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa
The objective of the project is to develop and test an intervention to promote exclusive breastfeeding (EBF), to assess its impact on infant health in African contexts where a high prevalence of HIV is a barrier, and to…
- Trial name
- NCT00397150
- Testing
- Peer-support for exclusive breastfeeding
- Where
- 4 sites in Burkina Faso, South Africa and 2 more
- Volunteers
- 2,579 people, healthy volunteers welcome
- Sponsor
- Centre For International Health
Breast Feeding, Breast Feeding, Exclusive
Alive & Thrive Evaluation in Burkina Faso
The time between birth and age 24 months provides a unique opportunity to impact the long-term health and development of children through improved infant and young child feeding practices.
- Trial name
- NCT02435524
- Testing
- A&T infant and young child feeding intervention
- Where
- 2 sites in Burkina Faso
- Volunteers
- 4,541 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Osteoporosis
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
Studies have shown that lactation is associated with a loss of bone density from four to seven percent at the spine and hip among women who lactate for six months. Decline in bone density with lactation occurs rapidly.
- Trial name
- NCT00903344
- Testing
- Vitamin D3, Multivitamin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Leigh Eck, MD
Risk Reduction
Social Media And Risk-reduction Training for Infant Care Practices (SMART)
The goal of this proposal is to address serious and ongoing challenges related to adherence to public health recommendations known to reduce the risk of SIDS.
- Trial name
- SMART (NCT01713868)
- Testing
- Safe Sleep Nursery Education, Breastfeeding Nursery Education, Breastfeeding Mobile Health Messaging
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Crohn's Disease, Ulcerative Colitis
Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease
Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications.
- Conditions
- Crohn's Disease, Ulcerative Colitis, Healthy Controls
- Trial name
- NCT03397108
- Testing
- The IBD group was divided into 2 subgroups: with or without anti-TNF antibody use
- Where
- 2 sites in Canada
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Vitamin D Deficiency
Establishing the Vitamin D Requirements During Lactation
The purpose of this study is to determine the effectiveness and safety of maternal and infant vitamin D supplementation as a function of ethnicity and latitude in the prevention of vitamin D deficiency in the breastfeeding…
- Trial name
- NCT00412074
- Testing
- 400 IU Vitamin D3 (cholecalciferol), 2400 IU Vitamin D3 (cholecalciferol), 6400 IU Vitamin D3 (cholecalciferol)
- Where
- 2 sites in United States
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Feeding and Eating Disorders of Childhood
Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.
- Trial name
- NCT00635453
- Testing
- Dietary Advice
- Where
- Brazil
- Volunteers
- 715 people
- Sponsor
- Federal University of Health Science of Porto Alegre
Breastfeeding Duration
BOOST: Breastfeeding Onset and Onward With Support Tools
This behavioral intervention trial will test whether a standard care breastfeeding intervention from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program plus monthly financial incentives…
- Trial name
- NCT03964454
- Testing
- WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI), WIC support + home-based individual support (SC)
- Where
- 2 sites in United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Philadelphia College of Osteopathic Medicine
Tobacco Use Disorder
Progesterone for Smoking Relapse Prevention Following Delivery
Smoking is the main preventable cause of mortality in Western countries, contributing to over 430,000 deaths a year in the U.S. alone.
- Trial name
- NCT01972464
- Testing
- Progesterone
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Yale University
HIV Infections, Herpes Simplex
HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
In this study, we will determine whether treating pregnant and breastfeeding women co-infected with human immunodeficiency virus type 1 (HIV-1) and herpes simplex virus type 2 (HSV-2) with daily valacyclovir will reduce HIV-1…
- Trial name
- VIP (NCT00530777)
- Testing
- valacyclovir
- Where
- Kenya
- Volunteers
- 148 people
- Sponsor
- University of Washington
Low Milk Supply, Pre-diabetes
Metformin to Augment Low Milk Supply (MALMS) Study
Most new mothers in the United States will start off breastfeeding. For some mothers, despite following best practices, they are not able to meet their breastfeeding goals due to unexplained low milk supply.
- Conditions
- Low Milk Supply, Pre-diabetes, Insulin Resistance, Suppressed Lactation
- Trial name
- MALMS (NCT02179788)
- Testing
- Standard care, Metformin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Breast Milk Expression
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes…
- Trial name
- NCT01892085
- Testing
- Early initiation, Intermediate expression, Late initiation
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University of Florida
Prematurity; Extreme, Feeding Disorder Neonatal
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z…
- Conditions
- Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure
- Trial name
- NCT04325308
- Testing
- Protein-enriched human milk diet, Usual human milk diet
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
HIV/AIDS
VITAL Start: Brief Facility-based Video Intervention
This a multi-center, parallel group, randomized controlled outcome assessor blinded trial with a qualitative descriptive component that seeks to assess the effectiveness of a brief facility-based video intervention to optimize…
- Trial name
- VITAL (NCT03654898)
- Testing
- VITAL Start: Video-based pre-ART counseling, Standard of Care
- Where
- Malawi
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Opioid Dependency
A Study of Breastfeeding in Buprenorphine Maintained Women
Goals: The overarching goals for this proposed research are to provide pilot data for a study to inform the FDA regarding the safety of breastfeeding infants of mothers on buprenorphine maintenance and to develop guidelines for…
- Trial name
- NCT01806389
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University
Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration…
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease
- Trial name
- CRADLE (NCT02154425)
- Testing
- Breast milk sampling, Certolizumab Pegol
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 17 people
- Sponsor
- UCB BIOSCIENCES, Inc.