Clinical trials: BREASTFEEDING
Healthy
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants.
- Trial name
- NCT01370967
- Testing
- Study formula feeding, Human milk feeding, Mixed feeding
- Where
- 24 sites in China
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Phenylketonuria, Maternal
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and…
- Trial name
- PALomino (NCT05579548)
- Testing
- Pegvaliase
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- BioMarin Pharmaceutical
Diarrhea, Acute Respiratory Infection
Oral Supplement for Pregnant and Lactating Mothers
To assess protection against early life infections through supplementation of mothers during pregnancy to the newborns' growth, morbidity, immune status intra and extra-uterine.
- Trial name
- NCT01073033
- Testing
- milk supplement 1, milk supplement 2
- Where
- Philippines
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Intestinal Absorption
Comparative A1 vs A2 Formula and Breast Feeding on Alimentation and Gastrointestinal Digestion for the Infant
This pilot study primarily aimed to compare effects of breast feeding, A1 versus A2®cow milk based formula on alimentation and gastrointestinal digestion.
- Trial name
- NCT03081936
- Testing
- Oral consumption of Nutricia Aptamil Stage 1 formula, Oral consumption of a2® Platinum Stage 1 formula, Oral consumption of breast milk
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
Healthy Infants
Comparative Effects of A2 Platinum Stage 1 Infant Formula on Infant Digestion and Comfort
This trial is a single-blind, randomized, controlled, parallel-designed trial to compare the effects of a2 Platinum® stage 1 infant formula versus conventional, A1 and A2 β-casein-containing stage 1 infant formula versus…
- Trial name
- NCT04733937
- Testing
- a2 Platinum® stage 1 infant formula, Conventional, A1 and A2 β-casein containing stage 1 infant formula
- Where
- 5 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
Infant Term Birth
Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.
- Trial name
- NCT02598817
- Testing
- Standard Infant Formula
- Where
- 5 sites in Saudi Arabia, United Arab Emirates
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
Hypoparathyroidism
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the…
- Trial name
- NCT07345494
- Testing
- Palopegteriparatide
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Ascendis Pharma A/S
Myasthenia Gravis, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy.
- Trial name
- NCT06299748
- Testing
- Efgartigimod
- Where
- 4 sites in United States, Germany and 2 more
- Volunteers
- 279 people
- Sponsor
- argenx
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
Friedreich Ataxia
A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA.
- Trial name
- NCT06628687
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Biogen
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Rezdiffra Pregnancy and Lactation Registry
To evaluate pregnancy and clinical outcomes in women with NASH and their infants after exposure to Rezdiffra at any time during pregnancy and/or lactation.
- Trial name
- NCT07541469
- Testing
- Rezdiffra
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Weaning
Impact of a Fermented Infant Formula in Weaning Babies
When mothers wanted to shift from breast milk to infant formulae, babies were randomly assigned to receive a fermented or a standard formula.
- Trial name
- NCT00858026
- Testing
- Breastmilk, Standard milk, Fermented milk
- Where
- 6 sites in France
- Volunteers
- 91 people
- Sponsor
- Bledina
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
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)
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
Fabry Disease, Pregnancy
Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to conception and/or during…
- Conditions
- Fabry Disease, Pregnancy, Pregnancy Complications
- Trial name
- MOS (NCT06941025)
- Testing
- Not applicable- observational study
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 10 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Malnutrition
Assessing Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices
The aim of this operational research is to compare the cost-effectiveness of two methods for capacity building of existing TBAs/CVs to improve rates of delayed cord clamping, early skin to skin contact and infant-led initiation…
- Trial name
- iycfch (NCT01407224)
- Testing
- Improve Early Breastfeeding
- Where
- Bangladesh
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Eminence
Healthy Growth
Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula
The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula.
- Trial name
- NCT05783037
- Testing
- New Organic Infant Formula, Commercial Organic Infant Formula
- Where
- United States
- Volunteers
- 394 people, healthy volunteers welcome
- Sponsor
- Bobbie Baby, Inc
Mucopolysaccharidosis I, Hurler's Syndrome
A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants
The purpose of this study is to determine if laronidase is present in the breast milk of post-partum women receiving Aldurazyme® (laronidase) and the effects of Aldurazyme (laronidase) on the growth, development, and immunologic…
- Conditions
- Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie
- Trial name
- NCT00418821
- Testing
- Laronidase
- Where
- Italy
- Volunteers
- 2 people
- Sponsor
- Genzyme, a Sanofi Company