Phase 4 Infant Clinical Trials

14 recruitingPhase 4

What is a Phase 4 trial?

Phase 4 trials, also called post-marketing studies, are conducted after a treatment has been approved and is available to the public. They monitor long-term effectiveness and safety in a broader population.

Showing 114 of 14 trials

Recruiting
Phase 4

Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes

Cerebral oxygen saturationInfant Respiratory Distress SyndromeCerebral Oxygenation+3 more
Medical University of Graz76 enrolled1 locationNCT07261787
Recruiting
Phase 4

Pediatric Long-Term Follow-up and Rollover Study

Neurofibromatosis Type 1GlioblastomaAnaplastic Astrocytoma+20 more
Novartis Pharmaceuticals165 enrolled55 locationsNCT03975829
Recruiting
Phase 4

Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome

SurfactantRespiratory Distress Syndrome in Premature InfantsRespiratory Distress Syndrome (RDS)
Uludag University234 enrolled5 locationsNCT07350018
Recruiting
Phase 4

Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

Premature BirthRespiratory Distress Syndrome in Premature InfantSurfactant Deficiency Syndrome Neonatal+1 more
Indiana University1,512 enrolled8 locationsNCT06554522
Recruiting
Phase 4

Treatment of Gastroesophageal Reflux Disease in Infants

Gastroesophageal RefluxInfant, Newborn, Diseases
Odense University Hospital96 enrolled3 locationsNCT06255886
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 4

Measles and BCG Vaccines for Mother and Child

Mother-Infant InteractionMeaslesVaccine Preventable Disease+1 more
Bandim Health Project2,400 enrolled1 locationNCT04899765
Recruiting
Phase 4

A Real World Study of the Effect of Early PEG-rhGH Therapy on Cognitive Development of SGA Infants

Growth Hormone TreatmentSmall for Gestational Age InfantCognitive Developmental Disorder
Tongji Hospital138 enrolled1 locationNCT05144035
Recruiting
Phase 4

Treating hypoglycaemia in newborns with Glucagon And Diazoxide: The Glad Study

HypoglycaemiaInfant of diabetic mother
Dr Lydia Kennedy100 enrolled1 locationACTRN12617001473358
Completed
Phase 4

Cuffed Versus Uncuffed Endotracheal Tubes for Ventilation of Neonates and Infants in the Neonatal and Paediatric Intensive Care Unit: A Pilot RCT

Artificial ventilation in neonates and infants
Princess Margaret Hospital74 enrolled1 locationACTRN12615000081516
Recruiting
Phase 3Phase 4

A randomised controlled trial of pneumococcal conjugate vaccines Synflorix and Prevenar13 in sequence or alone in high-risk Indigenous infants (PREV-IX): immunogenicity, carriage and otitis media outcomes

Non-typeable Haemophilus influenzae diseaseOtitis media in Indigenous infantsPneumococcal disease
Menzies School of Health Research425 enrolled1 locationACTRN12610000544077
Completed
Phase 4

More amino acids for prevention of extrauterine growth retardation in very low birth weight infants. A randomized controlled trial.

Growth of very low birth weight infants
Osp. Buon Consiglio60 enrolled1 locationACTRN12609001058268
Completed
Phase 4

A multi-site randomised controlled trial comparing regional and general anaesthesia for effects on neurodevelopmental outcome and apnoea in infants

Infant scheduled for unilateral or bilateral inguinal hernia repair
Professor Andrew Davidson720 enrolled6 locationsACTRN12606000441516
Completed
Phase 4

THE EFFECT OF PRETERM BIRTH ON OUTCOME - A RANDOMISED TRIAL OF PREVENTATIVE CARE

SURVIVING VERY PRETERM INFANTS(<30 WEEKS' GESTATIONAL AGE)
Royal Women's Hospital, Melbourne120 enrolled1 locationACTRN12605000492651