Clinical trials: Term Infants, open to volunteers
Prematurity, Infections, NIRS
The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates
This is a prospective, single-center Phase II observational study investigating the predictive value of the "Peripheral(-muscle) Oxygenation and Perfusion Score" (POP-Score), a novel non-invasive composite index, for early…
- Conditions
- Prematurity, Infections, NIRS, Near Infrared Spectroscopy, Preterm Neonates
- Trial name
- POP-Score (NCT07109856)
- Testing
- POP-Score Assessment, Near-Infrared Spectroscopy (NIRS)
- Where
- Austria
- Volunteers
- 93 people
- Sponsor
- Medical University of Graz
Skin-to-skin Contact
Skin-to-skin Contact in Healthy Term Infants
This is a prospective, double-blind, randomized controlled clinical trial study to investigate short- and long-term effects of mother-infant skin-to-skin contact in healthy term infants, in order to provide supporting data for…
- Trial name
- NCT06777524
- Testing
- skin-to-skin contact education
- Where
- 2 sites in South Korea
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Korea University Anam Hospital
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen
Infection, Bacterial, Infection Prevention
Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
NeoDeco is a pragmatic, multicenter, parallel-group, cluster-randomised hybrid effectiveness-implementation trial designed to evaluate the impact of implementing optimised Kangaroo Care (KC) at the unit level compared to standard…
- Trial name
- NeoDeco (NCT05993442)
- Testing
- Optimised kangaroo care
- Where
- 24 sites in Greece, Italy and 3 more
- Volunteers
- 3,080 people
- Sponsor
- PENTA Foundation
Healthy Infants
Probiotic for Infants
The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up…
- Trial name
- BABIES II (NCT07054216)
- Testing
- Probiotic
- Where
- 2 sites in Denmark
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Hvidovre University Hospital
Healthy Infants
Characterization of the Gastrointestinal Microbiota in Newborn Infants
The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1).
- Trial name
- BABIES I (NCT06789484)
- Testing
- Probiotic
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hvidovre University Hospital
Pregnancy Related
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12…
- Trial name
- NCT06258902
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ipsen
Skin to Skin Care for Preterm Infants
Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
The purpose of this study is to assess the impact of the Skincubator on average daily duration of Skin-to-skin Care (SSC), to assess the safety of Skincubator-supported SSC during NICU hospitalization, to evaluate feasibility and…
- Trial name
- NCT07721662
- Testing
- Skincubator-supported SSC, t-SSC
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- The University of Texas Health Science Center, Houston
Microbial Colonization
DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section.
The objective of this novel study is to establish proof of concept using a pilot randomized controlled trial to determine the effect of DHM compared to formula supplementation on the microbiome in full-term infants who are born…
- Trial name
- DO-RE-MI C-S (NCT06177184)
- Testing
- Donor Human Milk - Nutritional Replacement
- Where
- Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Infant Vitamin K Status, Vitamin K Deficiency Bleeding
The OK Daily Study
The OK Daily Study is a multi-centred, part-randomised, part blinded, four cohort study. We are exploring daily dietary supplementation with vitamin K2, specifically menaquinone-7 (MK-7), given to breastfed infants or…
- Trial name
- NCT07620236
- Testing
- Combined MK-7 + vitamin D3 drops, Vitamin D3 Drops, MK-7 capsules
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
Preterm Birth, Enterocolitis, Necrotizing
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Ulcerative-necrotizing enterocolitis (ECUN) is an infectious and inflammatory disease of the digestive tract, which can lead to intestinal necrosis or perforation.
- Trial name
- NECO2 (NCT05882448)
- Testing
- laparotomy, Laparoscopy
- Where
- 2 sites in France
- Volunteers
- 54 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Nutrition Intervention, Quality Improvement
Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
A clinical quality improvement bundle on early nutrition supplementation is developed to improving the clinical outcomes (including growth, organ function, and neurodevelopment outcomes) of extremely and/or very preterm infants.
- Conditions
- Nutrition Intervention, Quality Improvement, Preterm Infant
- Trial name
- NCT07538999
- Testing
- A nutritional improving bundle for the intervention group, Routine nutritional strategies for the control group
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Infant Nutritional Physiological Phenomena, Infant Formula
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
- Conditions
- Infant Nutritional Physiological Phenomena, Infant Formula, Infant Health, Infant Development
- Trial name
- NCT05868408
- Testing
- Control Formula, Experimental Formula 1, Experimental Formula 2
- Where
- 5 sites in Philippines, Saudi Arabia
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Preterm Infant Development, Preterm Infant Health
Pilot Study: Effects of CCP Intervention on NICU Environment and Preterm Infants Development
Close Collaboration with Parents intervention is an evidence-based educational intervention for the entire multi-professional staff of neonatal intensive care units (NICUs).
- Trial name
- NCT07306000
- Testing
- Close Collaboration with Parents training
- Where
- 3 sites in Japan, South Korea
- Volunteers
- 100 people
- Sponsor
- Turku University Hospital
Neonatal Hypoglycemia, Metabolic Complication
Pasteurised Donor Human Milk Supplementation for Term Babies
PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in…
- Conditions
- Neonatal Hypoglycemia, Metabolic Complication, Cows Milk Allergy, Hospital Length of Stay
- Trial name
- PRESENT (NCT06993103)
- Testing
- Standard care Cow's milk based formula, Dietary Supplement: PDHM Pasteurised Donor Human Milk
- Where
- 4 sites in Australia
- Volunteers
- 1,444 people
- Sponsor
- The University of Queensland
Neonatal Jaundice
Abdominal Massage for Newborn Jaundice
The goal of this clinical trial is to learn whether infant abdominal massage can help reduce bilirubin levels and improve bilirubin elimination in healthy full-term newborns.
- Trial name
- NCT07747220
- Testing
- Infant Abdominal Massage, Routine Newborn Care
- Where
- Taiwan
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Yueh-Chu Peng
Postpartum Anxiety, Postpartum Period
Short-Term Mindfulness Intervention for Anxiety and Maternal Attachment in NICU Mothers
This randomized controlled study aims to evaluate the effects of a short-term mindfulness-based stress reduction (MBSR) program on anxiety levels and maternal attachment in mothers whose infants are admitted to the Neonatal…
- Conditions
- Postpartum Anxiety, Postpartum Period, Maternal Behavior, Psychological Stress
- Trial name
- NCT07520435
- Testing
- Mindfulness-Based Stress Reduction (MBSR) Program
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Saglik Bilimleri Universitesi
Congenital Peumonia, Persistent Pulmonary Hypertension of Newborn
Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates
The aim of the study 1. To evaluate safety and efficacy of melatonin as an adjuvant therapy to inhaled nitric oxide generated by NO generator in the treatment of pulmonary hypertension in full term neonates. 2.
- Conditions
- Congenital Peumonia, Persistent Pulmonary Hypertension of Newborn, Congenital Diaphragmatic Hernia
- Trial name
- NCT07850934
- Testing
- Melatonin, nitric oxide generator
- Where
- Egypt
- Volunteers
- 52 people
- Sponsor
- Ain Shams University
Indirect Hyperbilirubinemia
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
This study aims to evaluate the effectiveness of adjunctive oral Bifidobacterium animalis subsp. lactis in term neonates with indirect hyperbilirubinemia receiving phototherapy.
- Trial name
- NCT07773012
- Testing
- Bifidobacterium animalis subsp. lactis, Standard Phototherapy
- Where
- Vietnam
- Volunteers
- 90 people
- Sponsor
- Can Tho University of Medicine and Pharmacy
Opioid-use Disorder, Opioid Use, Unspecified
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution…
- Conditions
- Opioid-use Disorder, Opioid Use, Unspecified, Buprenorphine Dependence
- Trial name
- Mother/BabyOUD (NCT03923374)
- Testing
- Subutex / Buprenorphine, Fetal & Neonatal MRI, DNA/Genetic/Pharmacokenetic Blood Draws
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Senthil Sadhasivam