Phase 3 Infant Clinical Trials

34 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 120 of 34 trials

Recruiting
Phase 3

Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome

Respiratory distress syndromePre-term Infants
Aerogen Pharma Limited520 enrolled12 locationsNCT06776783
Recruiting
Phase 2Phase 3

Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma

Infantile Hemangioma
West China Hospital40 enrolled1 locationNCT06798363
Not Yet Recruiting
Phase 2Phase 3

Effectiveness of topical timolol compared with oral propranolol for infant hemangiomas

Infantile hemangiomas
King edward Medical University Lahore40 enrolled1 locationACTRN12626000236392
Recruiting
Phase 3

A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects Aged 0 to <18

Glycogen Storage Disease Type II Infantile Onset
Amicus Therapeutics36 enrolled14 locationsNCT04808505
Not Yet Recruiting
Phase 3

Resuscitation of term or near term infants at birth with air or 100% oxygen (Resair 3) A Randomised Controlled Trial

Resuscitation of depressed term or near term infants at birth
University of Queensland240,000 enrolled9 locationsACTRN12625001364460
Recruiting
Phase 2Phase 3

BabySTrong II taVNS Feeding Trial

Feeding DelaysNeonates and Term Infants
Medical University of South Carolina88 enrolled1 locationNCT07049952
Recruiting
Phase 3

Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC

SafetyVaccinationChildren+3 more
Jean-Pierre Van geertruyden344 enrolled1 locationNCT06844487
Recruiting
Phase 3

Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)

HypoxiaInfant, Newborn, Diseases
Copenhagen Trial Unit, Center for Clinical Intervention Research1,610 enrolled1 locationNCT05907317
Recruiting
Phase 3

Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population

Cataracts Infantile
Salvat60 enrolled1 locationNCT05724446
Recruiting
Phase 3

Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)

Acute Lymphoblastic Leukemia, PediatricALL, Infants
Federal Research Institute of Pediatric Hematology, Oncology and Immunology80 enrolled1 locationNCT05029531
Recruiting
Phase 3Phase 4

Azithromycin at birth: Single dose azithromycin shortly before birth - what is the impact on infection rates in high-risk mothers and babies? A randomised controlled trial

infant infectionsmaternal post-natal infections
Menzies School of Health Research1,548 enrolled1 locationACTRN12624000247572
Recruiting
Phase 3

Reducing operative birth for fetal distress in women with small or suboptimally grown infants - The RidStress 2 Randomised Controlled Trial

Small for gestational age infantsOperative birth (caesarean or instrumental birth)Birth asphyxia
Mater Misericordiae Ltd660 enrolled4 locationsACTRN12621000354886
Completed
Phase 2Phase 3

Randomised controlled trial: Can topical timolol maleate prevent complications and reduce the need for further treatment for small superficial infantile haemangiomata in high risk areas?

Infantile Haemangioma
United Christian Hospital64 enrolled1 locationACTRN12619001685101
Completed
Phase 3

Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women

Infant anaemiaMaternal mortalityFatigue+5 more
University of Malawi, College of Medicine862 enrolled1 locationACTRN12618001268235
Active
Phase 3

Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: Effects on Outcome (TORPIDO 30/60)

Premature infants requiring resuscitation at birth
University of Sydney1,470 enrolled13 locationsACTRN12618000879268
Recruiting
Phase 3

Intravenous pentoxifylline as adjunct therapy to improve long-term disability in preterm infants

Late-onset sepsis (LOS)Preterm infantsNecrotising enterocolitis (NEC)+1 more
University of Sydney1,800 enrolled25 locationsACTRN12616000405415
Suspended
Phase 2Phase 3

The Torpido2 Study: Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: Effects on developmental Outcome

Oxidative stress in premature infantsBronchopulmonary dysplasia in premature infantsResuscitation of premature infants+2 more
University of Sydney1,200 enrolled5 locationsACTRN12615000115538
Completed
Phase 3

MAGENTA - Magnesium Sulphate at 30 to 34 weeks' gestational age: Neuroprotection Trial

Complications of preterm infantCerebral PalsyNeuroprotection
University of Adelaide1,676 enrolled1 locationACTRN12611000491965
Recruiting
Phase 2Phase 3

The To2rpido Study: Targeted Oxygenation in the Resuscitation of Premature Infants and their Developmental Outcome

Oxidative stress in premature infantsBronchopulmonary dysplasia in premature infantsResuscitation in premature infants+1 more
The Royal Hospital for Women1,892 enrolled1 locationACTRN12610001059055
Terminated
Phase 2Phase 3

Aerosolized surfactant in the first hour of life

Infant Respiratory Distress Syndrome
School of Women’s and Infants’ Health (SWIH)110 enrolled1 locationACTRN12610000857000