Skip to content
Pharma Observatory a Scientist.com platform

Condition (MeSH)

Infant, Newborn, Diseases

ClinicalTrials.gov lists 3,634 trials for Infant, Newborn, Diseases or a narrower condition beneath it. Vertex Pharmaceuticals Incorporated has the most among industry and government lead sponsors, with 117.

MeSH D007232 Congenital / Hereditary / Neonatal C16
Email me this page as a PDF

Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.

Phase 1 Phase 1 239 Phase 1/2 Phase 1/2 128 Phase 2 Phase 2 347 Phase 2/3 Phase 2/3 63 Phase 3 Phase 3 310 Phase 4 Phase 4 183 Not applicable Not applicable 1,219 Observational Observational 1,130 Phase 1 Phase 1 239 Phase 1/2 Phase 1/2 128 Phase 2 Phase 2 347 Phase 2/3 Phase 2/3 63 Phase 3 Phase 3 310 Phase 4 Phase 4 183 Not applicable Not applicable 1,219 Observational Observational 1,130

Trials per phase

2 more sections with rows

139 of the 3,634 trials are tagged with Infant, Newborn, Diseases itself; the rest are tagged with a narrower condition beneath it.

Get the Infant, Newborn, Diseases report as a PDF

The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Infant, Newborn, Diseases trials start? (37)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 11 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational
  • Other (Unknown)

Top of scale: 224

1990: 2 trials (Observational 2) 1991: 5 trials (Observational 2, Not applicable 1, Phase 3 1, Phase 2/3 1) 1992: 4 trials (Observational 1, Not applicable 1, Phase 3 1, Phase 1/2 1) 1993: 6 trials (Observational 2, Phase 3 3, Phase 1 1) 1994: 3 trials (Observational 1, Not applicable 1, Phase 2/3 1) 1995: 12 trials (Observational 1, Phase 3 4, Phase 2/3 1, Phase 2 2, Phase 1/2 1, Phase 1 3) 1996: 13 trials (Observational 5, Not applicable 2, Phase 3 3, Phase 2 2, Phase 1/2 1) 1997: 9 trials (Observational 1, Not applicable 3, Phase 4 1, Phase 3 1, Phase 2/3 1, Phase 1 2) 1998: 9 trials (Observational 4, Not applicable 2, Phase 3 2, Phase 1 1) 1999: 13 trials (Observational 4, Not applicable 4, Phase 4 2, Phase 2 2, Phase 1 1) 2000: 14 trials (Observational 3, Not applicable 1, Phase 3 5, Phase 2/3 2, Phase 2 2, Phase 1/2 1) 2001: 33 trials (Observational 12, Not applicable 4, Phase 4 4, Phase 3 4, Phase 2/3 1, Phase 2 2, Phase 1/2 3, Phase 1 3) 2002: 19 trials (Observational 4, Not applicable 4, Phase 3 5, Phase 2/3 1, Phase 2 1, Phase 1/2 2, Phase 1 2) 2003: 20 trials (Observational 1, Not applicable 3, Phase 4 1, Phase 3 4, Phase 2/3 1, Phase 2 6, Phase 1/2 3, Phase 1 1) 2004: 40 trials (Observational 14, Not applicable 8, Phase 3 3, Phase 2/3 2, Phase 2 6, Phase 1/2 1, Phase 1 6) 2005: 56 trials (Observational 10, Not applicable 10, Phase 4 4, Phase 3 13, Phase 2/3 2, Phase 2 12, Phase 1/2 3, Phase 1 2) 2006: 83 trials (Observational 22, Not applicable 22, Phase 4 6, Phase 3 8, Phase 2/3 2, Phase 2 12, Phase 1/2 1, Phase 1 10) 2007: 84 trials (Observational 23, Not applicable 14, Phase 4 9, Phase 3 13, Phase 2/3 1, Phase 2 14, Phase 1/2 8, Phase 1 2) 2008: 115 trials (Observational 21, Not applicable 30, Phase 4 9, Phase 3 15, Phase 2/3 2, Phase 2 22, Phase 1/2 4, Phase 1 12) 2009: 107 trials (Observational 22, Not applicable 25, Phase 4 11, Phase 3 16, Phase 2/3 2, Phase 2 15, Phase 1/2 5, Phase 1 11) 2010: 126 trials (Observational 33, Not applicable 27, Phase 4 8, Phase 3 20, Phase 2/3 1, Phase 2 22, Phase 1/2 5, Phase 1 10) 2011: 123 trials (Observational 37, Not applicable 32, Phase 4 11, Phase 3 12, Phase 2/3 4, Phase 2 15, Phase 1/2 6, Phase 1 6) 2012: 130 trials (Observational 34, Not applicable 40, Phase 4 9, Phase 3 11, Phase 2/3 4, Phase 2 19, Phase 1/2 6, Phase 1 7) 2013: 145 trials (Observational 46, Not applicable 39, Phase 4 12, Phase 3 14, Phase 2/3 2, Phase 2 12, Phase 1/2 5, Phase 1 15) 2014: 147 trials (Observational 43, Not applicable 53, Phase 4 5, Phase 3 9, Phase 2 21, Phase 1/2 3, Phase 1 13) 2015: 171 trials (Observational 48, Not applicable 58, Phase 4 9, Phase 3 17, Phase 2/3 6, Phase 2 16, Phase 1/2 4, Phase 1 13) 2016: 188 trials (Observational 61, Not applicable 74, Phase 4 10, Phase 3 11, Phase 2 18, Phase 1/2 6, Phase 1 8) 2017: 182 trials (Other 1, Observational 51, Not applicable 61, Phase 4 9, Phase 3 16, Phase 2/3 2, Phase 2 23, Phase 1/2 3, Phase 1 16) 2018: 203 trials (Observational 66, Not applicable 73, Phase 4 7, Phase 3 17, Phase 2/3 1, Phase 2 13, Phase 1/2 13, Phase 1 13) 2019: 224 trials (Observational 84, Not applicable 81, Phase 4 6, Phase 3 14, Phase 2/3 2, Phase 2 23, Phase 1/2 6, Phase 1 8) 2020: 198 trials (Observational 75, Not applicable 76, Phase 4 9, Phase 3 17, Phase 2/3 3, Phase 2 7, Phase 1/2 3, Phase 1 8) 2021: 208 trials (Observational 75, Not applicable 88, Phase 4 7, Phase 3 11, Phase 2/3 2, Phase 2 12, Phase 1/2 5, Phase 1 8) 2022: 202 trials (Observational 69, Not applicable 89, Phase 4 7, Phase 3 11, Phase 2/3 1, Phase 2 8, Phase 1/2 3, Phase 1 14) 2023: 189 trials (Observational 73, Not applicable 76, Phase 4 10, Phase 3 5, Phase 2/3 4, Phase 2 6, Phase 1/2 6, Phase 1 9) 2024: 210 trials (Observational 72, Not applicable 88, Phase 4 6, Phase 3 7, Phase 2/3 3, Phase 2 15, Phase 1/2 9, Phase 1 10) 2025: 148 trials (Observational 48, Not applicable 59, Phase 4 6, Phase 3 8, Phase 2/3 7, Phase 2 6, Phase 1/2 4, Phase 1 10)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 141
2025 148
2024 210
2023 189
2022 202
2021 208
2020 198
2019 224
2018 203
2017 182

Showing 10 of 37 earlier years.

Start your 14-day trial Email me all 37 earlier years as a PDF

Forecast of the full-year count, planned starts included, not rows of this table: about 160 trials starting in 2026 and about 160 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 13 percent and ran about 12 percent low against the count later registered; forecasts made before the year began were off by about 19 percent and ran about 17 percent low against the count later registered, and had about the same error as repeating last year's count. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 227 trials still running at the 2026-10-09 snapshot; registered median of 21 months across 2,359 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Infant, Newborn, Diseases trials in? (10)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 239
Phase 1/2 128
Phase 2 347
Phase 2/3 63
Phase 3 310
Phase 4 183
Not applicable 1,219
Observational 1,130
Expanded access 14
Unknown 1

How many Infant, Newborn, Diseases trials are recruiting? (12)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 139
Recruiting 344
Enrolling by invitation 27
Active, not recruiting 98
Available 2

Showing 5 of 12 statuses.

Start your 14-day trial Email me all 12 statuses as a PDF

Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Infant, Newborn, Diseases trials? (3)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
Vertex Pharmaceuticals Incorporated 117
NICHD Neonatal Research Network 31
National Center for Research Resources (NCRR) 25

Which drugs are being tested for Infant, Newborn, Diseases? (6)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
Ivacaftor 52
IVA 46
SILDENAFIL 22
Lactobacillus reuteri 12
CREON 12

Showing 5 of 6 drugs.

Start your 14-day trial Email me all 6 drugs as a PDF

Interventions as named in the registry (9)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
tobramycin / TOBI 28
ELX/TEZ/IVA 23
1% Azithromycin 17
TEZ/IVA 13
Exercise 13

Showing 5 of 9 interventions.

Start your 14-day trial Email me all 9 interventions as a PDF

These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Infant, Newborn, Diseases trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Infective pulmonary exacerbation of cystic fibrosis 2,530 96
Patent Ductus Aretriosus 631 1
Death 425 9
Haemoptysis 311 71
Cystic fibrosis lung 298 16

Showing 5 of 10 adverse events.

Start your 14-day trial Email me all 10 adverse events as a PDF

Which publications cover Infant, Newborn, Diseases? (618)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Haemodynamic assessment and management of hypotension in the preterm. Archives of disease in childhood. Fetal and neonatal edition 2024 Yes
Blood Pressure Outcomes in NICU-Admitted Infants with Neonatal Hypertension: A Pediatric Nephrology Research Consortium Study. The Journal of pediatrics 2024 Yes
Feasibility and Safety of Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia (SANE-01): A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Trial. The Journal of pediatrics 2024 Yes
Music therapy and weight gain in preterm infants: Secondary analysis of the randomized controlled LongSTEP trial. Journal of pediatric gastroenterology and nutrition 2024 Yes
MicroRNAs as biomarkers of brain injury in neonatal encephalopathy: an observational cohort study. Scientific reports 2024 Yes

Showing 5 of 618 publications.

Start your 14-day trial Email me the first 50 publications as a PDF

Sub-conditions in MeSH (29)

MeSH descendants one level down with at least one trial, most trials first.

+19 more sub-conditions

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence and rare-disease identity.

Browse all condition evidence pages