Clinical trials: Lactation
Breastfeeding
Pilot Study of the FEEDBACK System for Use With Infants in the Neonatal Intensive Care Unit at University of Virginia
The purpose of this study is to assess the accuracy of FEEDBACK for measuring breastmilk intake of a pre-term baby. Mothers and babies will use the FEEDBACK system during a breastfeeding session in the NICU.
- Trial name
- NCT03702686
- Testing
- FEEDBACK System
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Molex Ventures LLC
Healthy Participant
A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding Women
This study aims to figure out how much etrasimod, a medication, ends up in breast milk after taking it for several days. To do this, the researchers will work with at least 8 healthy women who are breastfeeding.
- Trial name
- NCT07153159
- Testing
- Etrasimod
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
Infant Term Birth
Breastfeeding Study
The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants.
- Trial name
- NCT03387124
- Testing
- Breastfed infants
- Where
- Philippines
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Breastfeeding Mothers
Atlas of Human Milk Nutrients
The main objective of this clinical trial is to collect human milk samples from 0 to 4 months after delivery in order to characterize human milk components. The secondary objectives of this study are: 1.
- Trial name
- NCT01894893
- Where
- 13 sites in France, Italy and 5 more
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Breast Milk Collection
Odour Characteristics of Human Breast Milk of Chinese Mothers
It is well known that breast milk exerts many positive effects on the general health, growth and development of infants. When breastfeeding is not possible, infant formula is considered to be an effective substitute to satisfy…
- Trial name
- NCT05133466
- Where
- China
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Chronic Idiopathic Constipation (CIC)
A Study of Prucalopride in Breastfeeding Women With Constipation
Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk.
- Trial name
- NCT04838522
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Takeda
Breast Fed Infants
Plasma Profile of Exclusively Breastfed Infants
To characterize nutrient levels in breastfeeding infants and their mothers.
- Trial name
- NCT01669655
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Pompe Disease, Pregnancy
Avalglucosidase Alfa Pregnancy Study
This is a worldwide, descriptive safety study collecting data on women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation, to assess the risks of avalglucsodiase alfa on pregnancy and maternal…
- Trial name
- NCT05734521
- Testing
- avalglucosidase alfa-NGPT (GZ402666) IV, avalglucosidase alfa-NGPT (GZ402666)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Sanofi
Lactation
Impact of Breast Shield Designs on Dynamics of Breast Pumping
A prospective, randomized, 2-phase/crossover, single center premarket feasibility study. In phase I the comfort will be assessed, the occurence and types of adverse events will be recorded and the assessment how and if the…
- Trial name
- BSD (NCT02719548)
- Testing
- Soft edge oval - Hard oval - Modified PF breast shield, Modified PF breast shield - Soft edge oval - Hard oval, Hard oval - Soft edge oval - Modified PF breast shield
- Where
- Switzerland
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Medela AG
Breast Milk
Human Milk Profiles and Dietary Intake of Chinese Lactating Mothers During Early Lactation Period in Shanghai
This study aims to investigate breast milk composition and dietary habits of Chinese lactating mothers. Further understanding of the composition of human milk will help to understand the nutritional needs of mothers and their…
- Trial name
- MuRu (NCT02070562)
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Dumex Baby Food Co., Ltd.
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Renal Anemia, Pregnancy
Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia
The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered…
- Conditions
- Renal Anemia, Pregnancy, Lactation
- Trial name
- PASCO II (NCT01543477)
- Where
- 179 sites in Bulgaria, Croatia and 10 more
- Volunteers
- 4,501 people
- Sponsor
- Pfizer
Psoriasis, Colitis, Ulcerative
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the…
- Conditions
- Psoriasis, Colitis, Ulcerative, Crohn Disease, Arthritis, Psoriatic
- Trial name
- NCT07654751
- Testing
- Breast Milk Sample Collection, Guselkumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Janssen Research & Development, LLC
Breastfeeding, Patient Simulation
Evaluation of Health Professional Learners' Competence in Newborn Positioning and Attachment Following a Standardized Patient-led Lactation Skills Workshop
Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating…
- Trial name
- NCT04717128
- Testing
- Breastfeeding Skills Workshop
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- LiquidGoldConcept
Anaemia
Safety and Efficacy Study of a Food Supplement for Pregnant and Lactating Women
The purpose of this study is to determine whether a food supplement consisting of vitamins, minerals and fish oil taken during and after pregnancy can decrease the need for additional iron supplementation due to anemia during…
- Trial name
- NCT02190565
- Testing
- Food supplement
- Where
- Sweden
- Volunteers
- healthy volunteers welcome
- Sponsor
- Oriflame Cosmetics AB
Transthyretin Amyloidosis
The Eplontersen Pregnancy and Lactation Outcomes Study
The overall objective of this DPSS is to describe the occurrence of pregnancy and maternal complications, adverse effects on the developing fetus and neonate, and adverse effects on the infant associated with exposure to…
- Trial name
- EPPRO (NCT07205666)
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Glycogen Storage Disease, Pompe Disease
Pompe Lactation Sub-Registry
The objective is to determine if alglucosidase alfa is present in breast milk from mothers with Pompe Disease being treated with alglucosidase alfa and to measure breast milk production and composition in women with Pompe Disease…
- Trial name
- NCT00566878
- Testing
- alglucosidase alfa
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Genzyme, a Sanofi Company