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Premature Birth clinical trials

The registry lists 2,553 studies for Premature Birth across more than 10 countries. 502 are recruiting or about to start. 1,758 of them are mainly about Premature Birth (how this is decided). Per ClinicalTrials.gov, last updated 2026-11-12.

ClinicalTrials.gov finds 4,383 studies for Premature Birth. How that becomes 2,547 here

This page counts the studies the registry files under Premature Birth, and those it files under no condition that list Premature Birththemselves. Each study its search finds is placed by how the registry filed it and by the conditions it lists. ClinicalTrials.gov counts as of Nov 8, 2026. How condition pages count

  1. 4,383Found by its condition searchIt reads the conditions a study lists and their synonyms, and also titles and keywords.
  2. −18List Premature Birth as a condition, but the registry did not file them under itMost often written as “Preterm Birth Complication” (9), “Patent Ductus Arteriosus After Premature Birth” (6), and “Very Preterm Birth” (1). The registry filed them under other conditions only, most often Ductus Arteriosus, Patent (6) and Digestive System Diseases (2).
  3. −1,818Match it another way46 name it in the title, 3 in a keyword, and 1,769 by a synonym or other text the search reads.
  4. 2,547The count on this page16 of them list Premature Birth in their own words; the registry filed them under no condition.

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Status

Completed
1,396
Status unknown
329
Recruiting
315
Not yet recruiting
164
Terminated
150
Active, not recruiting
99

Phase

Phase 3
182
Phase 2
163
Phase 4
119
Phase 1
85
Early Phase 1
15

Where

United States
741
Turkey
247
France
205
Canada
139
Italy
119
United Kingdom
100

Who runs them

NICHD Neonatal Research Network (41) · University of Alabama at Birmingham (29) · Assistance Publique - Hôpitaux de Paris (26) · University of Utah (19) · Ain Shams University (19) · Christiana Care Health Services (18) · University of Pennsylvania (16) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (16)

What is being tested here

Drugs under test in Premature Birth studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted

DrugOpenPhase 3All
Caffeine7414
Caffeine citrate6411
Azithromycin4310
Metformin448
Poractant alfa417
Aspirin329
Amoxicillin303
Budesonide215
Ampicillin214
Erythromycin204

Drug classes tested here Stimulants 7 open · NSAIDs 4 open · Corticosteroids 3 open · Progestins 1 open · Opioids 1 open

Coming up

32phase 3 studies under way
148studies finish main data collection within a year4 of them phase 3

Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.

The 10 nearest, phase 3 first

Who these studies take

Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger. 241 (77%) take children under 18. 76 (24%) are for women only and 2 (1%) for men only; 105 (33%) take healthy volunteers.

Recruiting studies that take each age, of 315
AgeWomenMen
1048 (15%)39 (12%)
18124 (39%)55 (17%)
30124 (39%)51 (16%)
40122 (39%)50 (16%)
50106 (34%)48 (15%)
6593 (30%)45 (14%)
7592 (29%)45 (14%)
8590 (29%)44 (14%)

Across all 2,553 studies, recruiting or not: 76% stop at 75 or younger and 76% at 65; 79% take children; 24% are for women only and 1% for men only; 31% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.

How long Premature Birth studies take

Of 54 phase 4 interventional studies under Premature Birth, half reached primary completion within 25 months of starting, counting those still running.

Start to primary completionEvery sponsorIndustryNon-industry
Phase 112 mo6–36 · 29 studies——
Phase 237 mo25–52 · 31 studies——
Phase 351 mo28–89 · 40 studies—53 mo28–89 · 35 studies
Phase 425 mo13–60 · 54 studies—25 mo13–60 · 54 studies
Interventional, no phase24 mo12–47 · 762 studies—24 mo12–47 · 744 studies
Observational35 mo18–61 · 387 studies—35 mo18–63 · 372 studies

Each figure is the month by which half the studies had reached primary completion, with the range in which the middle half did. Studies still running count until their last registry update; studies that stopped early are left out. Phase 1 includes early phase 1; observational means prospective or not stated, as retrospective and cross-sectional studies date a window of data rather than a study. How these figures are worked out

What changed recently

From the registry's own updates since Oct 14, 2026.

Started recruiting9

Show 4 more

Newly registered21

Show 16 more

Studies

Recruiting first, then most recently updated. Showing 50 of 2,553. Browse all 2,553 → or search them.