Phase 3 Neonatal Clinical Trials

14 recruitingPhase 3

What is a Phase 3 trial?

Phase 3 trials compare the new treatment against the current standard of care in large groups, often hundreds to thousands of participants. Successful Phase 3 results are typically required for regulatory approval.

Showing 114 of 14 trials

Recruiting
Phase 3

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Thrombocytopenia, Neonatal Alloimmune
Janssen Research & Development, LLC39 enrolled21 locationsNCT06449651
Recruiting
Phase 3

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Thrombocytopenia, Neonatal Alloimmune
Janssen Research & Development, LLC50 enrolled24 locationsNCT06533098
Recruiting
Phase 3

Cooling in Mild Encephalopathy

Neonatal EncephalopathyNewborn Asphyxia
Imperial College London426 enrolled39 locationsNCT05889507
Recruiting
Phase 2Phase 3

A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women

Neonatal SepsisPneumoniaInfections+6 more
Minervax ApS338 enrolled6 locationsNCT06592586
Recruiting
Phase 3

Neonatal Brain Ultrasound With CEUS and Elastography

Neonatal Hypoxic Ischemic EncephalopathyNeonatal StrokeNeonatal Encephalopathy, Unspecified
Turku University Hospital100 enrolled1 locationNCT05648812
Recruiting
Phase 3

Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Neonatal Infection
Harvard School of Public Health (HSPH)3,250 enrolled1 locationNCT06102044
Recruiting
Phase 3

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

Intubation ComplicationRespiratory Distress Syndrome (Neonatal)Death; Neonatal
ONY220 enrolled10 locationsNCT05960929
Recruiting
Phase 3

Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition

Metabolic AcidosisNeonatal DiseaseNeonatal Complication
Aga Khan University Hospital, Pakistan200 enrolled1 locationNCT06545565
Recruiting
Phase 3

The C*STEROID Trial: Corticosteroids before planned caesarean section from 35+0 to 39+6 weeks of pregnancy.

Transient tachypnoea of the newbornNeonatal hypoglycaemiaCaesarean section delivery+1 more
The University of Auckland2,548 enrolled23 locationsACTRN12620000914965
Completed
Phase 2Phase 3

Diazoxide for babies with severe or recurrent low blood glucose: The Neonatal Glucose Care Optimisation (NeoGluCO) Study

Neonatal hypoglycaemia
Liggins Institute, University of Auckland74 enrolled1 locationACTRN12620000129987
Completed
Phase 2Phase 3

PRECeDe Pilot: Prevention of neonatal Respiratory distress with antenatal corticosteroids prior to Elective Caesarean section in women with Diabetes - A Feasibility Randomised Trial

DiabetesGestational DiabetesNeonatal respiratory distress
Western Health50 enrolled1 locationACTRN12619001475134
Recruiting
Phase 3

Citicoline as Neuroprotector in Neonates Exposed to Hypoxia

Neonatal Hypoxia
Sherief Abd-Elsalam40 enrolled1 locationNCT03949049
Terminated
Phase 3

The C*STEROID Feasibility Study: a two-site, randomised placebo controlled trial of corticosteroids before planned caesarean section delivery at 35+0 to 39+6 weeks of pregnancy to determine feasibility for recruitment to the C*STEROID Trial.

Transient tachypnoea of the newbornNeonatal hypoglycaemiaCaesarean section delivery+1 more
University of Auckland400 enrolled1 locationACTRN12618002028280
Completed
Phase 3

PAEAN – Erythropoietin for hypoxic ischaemic encephalopathy in newborns

neonatal hypoxic ischaemic encephalopathy
University of Sydney300 enrolled21 locationsACTRN12614000669695