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
- 4,383Found by its condition searchIt reads the conditions a study lists and their synonyms, and also titles and keywords.
- −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).
- −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.
- 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
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
| Drug | Open | Phase 3 | All |
|---|---|---|---|
| Caffeine | 7 | 4 | 14 |
| Caffeine citrate | 6 | 4 | 11 |
| Azithromycin | 4 | 3 | 10 |
| Metformin | 4 | 4 | 8 |
| Poractant alfa | 4 | 1 | 7 |
| Aspirin | 3 | 2 | 9 |
| Amoxicillin | 3 | 0 | 3 |
| Budesonide | 2 | 1 | 5 |
| Ampicillin | 2 | 1 | 4 |
| Erythromycin | 2 | 0 | 4 |
Drug classes tested here Stimulants 7 open · NSAIDs 4 open · Corticosteroids 3 open · Progestins 1 open · Opioids 1 open
Coming up
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
- Nov 2026Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation · Phase 3 · Assistance Publique - Hôpitaux de Paris
- Dec 2026Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants · Phase 3 · University Hospital Tuebingen
- Aug 2027Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants · Phase 3 · University of California, Davis
- Oct 2027Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress · Phase 3 · Ministry of Health, Saudi Arabia
- Nov 2026Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates · Uskudar University
- Nov 2026Genesis Electrical Impedance Tomography (EIT): A Preliminary Study · University of Colorado, Denver
- Nov 2026Best Practices Fo Early Diagnosis of Cerebral Palsy · St. Justine's Hospital
- Nov 2026Gut Microbiota of Preterm Infants and Full-term Infants at Early Life · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Nov 2026The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants · Mersin University
- Nov 2026Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial). · Murdoch Childrens Research Institute
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.
| Age | Women | Men |
|---|---|---|
| 10 | 48 (15%) | 39 (12%) |
| 18 | 124 (39%) | 55 (17%) |
| 30 | 124 (39%) | 51 (16%) |
| 40 | 122 (39%) | 50 (16%) |
| 50 | 106 (34%) | 48 (15%) |
| 65 | 93 (30%) | 45 (14%) |
| 75 | 92 (29%) | 45 (14%) |
| 85 | 90 (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 completion | Every sponsor | Industry | Non-industry |
|---|---|---|---|
| Phase 1 | 12 mo6–36 · 29 studies | — | — |
| Phase 2 | 37 mo25–52 · 31 studies | — | — |
| Phase 3 | 51 mo28–89 · 40 studies | — | 53 mo28–89 · 35 studies |
| Phase 4 | 25 mo13–60 · 54 studies | — | 25 mo13–60 · 54 studies |
| Interventional, no phase | 24 mo12–47 · 762 studies | — | 24 mo12–47 · 744 studies |
| Observational | 35 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
- Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled TrialNov 12, 2026NCT07645677
- Home Play-based Intervention for Parents and InfantsNov 12, 2026NCT07716072
- Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical StudyNov 6, 2026NCT07545993
- REspiratory MEchanics for Delivering Individualised Exogenous SurfactantNov 5, 2026NCT05791331
- Preeclampsia Intervention NetherlandsNov 4, 2026NCT06452498
Show 4 moreShow fewer
- Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm NeonatesOct 27, 2026NCT06377397
- The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.Oct 23, 2026NCT07787845
- The Correlation Between Red Cell Transfusion and Complications of PrematurityOct 22, 2026NCT07123948
- Cervical Stiffness in Women With Threatened Preterm LaborOct 21, 2026NCT07840235
Newly registered21
- Continuous vs Intermittent Kangaroo Mother Care and Weight Gain in Low Birth Weight InfantsNov 12, 2026NCT07930845
- Neonatal AI-Based Early Warning System for Late-Onset Sepsis and Necrotizing Enterocolitis in the NICU: Assessment of Response and EffectivenessNov 12, 2026NCT07931144
- Effect of Earmuffs on Physiological Stability, Sleep-Wake States, and Weight Gain in Preterm NeonatesNov 12, 2026NCT07934238
- Evaluation of an Early Preventive and Educational Care Pathway for Moderate and Late Preterm Infants. A Randomized Controlled StudyNov 10, 2026NCT07928830
- Daily Physical Activity and Irisin, Adiponectin, and C-Peptide in Preterm InfantsNov 9, 2026NCT07924631
Show 16 moreShow fewer
- NAVA Use in Preterm Neonates With Respiratory Distress SyndromeNov 9, 2026NCT07926009
- nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 WeeksNov 6, 2026NCT07923604
- Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm InfantsNov 5, 2026NCT07917871
- Cervical Length Reference Range at 28-34 Weeks in Singleton PregnanciesNov 3, 2026NCT07914595
- Maximising Maternal Milk for Preterm InfantNov 2, 2026NCT07908238
- Rectal Administration of Mother's Own Milk and Growth in Preterm InfantsNov 2, 2026NCT07908966
- Late Low-Dose Dexamethasone in Preterm Neonates Using DART ProtocolOct 29, 2026NCT07904104
- The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm InfantsOct 27, 2026NCT07896824
- Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)Oct 26, 2026NCT07894380
- Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover TrialOct 26, 2026NCT07895654
- Impact of Higher Zinc Supplementation on Neonatal Weight VelocityOct 26, 2026NCT07896070
- Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of LifeOct 23, 2026NCT07892209
- Efficacy of a Video-based, Parent-centered Home Developmental Intervention for Infants at High Risk for Developmental Delay: a Multicenter Randomized Controlled TrialOct 20, 2026NCT07882199
- Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding OutcomesOct 20, 2026NCT07883707
- Post-Care Positioning and Comfort in Late Preterm InfantsOct 19, 2026NCT07881653
- Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate RiskOct 16, 2026NCT07878819
Studies
Recruiting first, then most recently updated. Showing 50 of 2,553. Browse all 2,553 → or search them.
- Effect of Earmuffs on Physiological Stability, Sleep-Wake States, and Weight Gain in Preterm NeonatesNot yet recruitingNCT07934238Not applicable1 country
- Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled TrialRecruitingNCT07645677Not applicable1 country
- Home Play-based Intervention for Parents and InfantsRecruitingNCT07716072Not applicable1 country
- Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for NeonatesNot yet recruitingNCT07060911Not applicable1 country
- Neonatal AI-Based Early Warning System for Late-Onset Sepsis and Necrotizing Enterocolitis in the NICU: Assessment of Response and EffectivenessNot yet recruitingNCT07931144Not applicable2 countries
- Cervical Length Reference Range at 28-34 Weeks in Singleton PregnanciesNot yet recruitingNCT079145951 country
- Retinopathy of Prematurity - Visual Function and Retinal StructureNot yet recruitingNCT074277191 country
- Evaluation of an Early Preventive and Educational Care Pathway for Moderate and Late Preterm Infants. A Randomized Controlled StudyNot yet recruitingNCT07928830Not applicable
- nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 WeeksNot yet recruitingNCT07923604Not applicable1 country
- NAVA Use in Preterm Neonates With Respiratory Distress SyndromeRecruitingNCT07926009Not applicable1 country
- Improving Preterm Kidney Outcomes With CaffeineRecruitingNCT07262060Phase 21 country
- Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing EnterocolitisRecruitingNCT05882448Not applicable1 country
- Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical StudyRecruitingNCT075459931 country
- Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)RecruitingNCT05849077Not applicable1 country
- Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm InfantsNot yet recruitingNCT07917871Not applicable1 country
- Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of LifeNot yet recruitingNCT07892209
- REspiratory MEchanics for Delivering Individualised Exogenous SurfactantRecruitingNCT05791331Not applicable1 country
- Growing Little PEAPODS StudyRecruitingNCT062260511 country
- Preeclampsia Intervention NetherlandsRecruitingNCT06452498Phase 31 country
- Effect of Antenatal Dexamethasone on Postnatal Adrenal Hormones in Preterm NeonatesNot yet recruitingNCT079161421 country
- A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had PreeclampsiaNot yet recruitingNCT06798649Not applicable
- Effect of Support for Low-Income Mothers of Preterm InfantsRecruitingNCT06362798Not applicable1 country
- Maximising Maternal Milk for Preterm InfantRecruitingNCT07908238Not applicable1 country
- Little Lungs StudyNot yet recruitingNCT06855043Phase 1/21 country
- The Periviable GOALS Decision Support ToolRecruitingNCT05264779Not applicable1 country
- Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based TrialNot yet recruitingNCT07553286Phase 3
- Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0Enrolling by invitationNCT0682311533 countries
- Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm NeonatesRecruitingNCT06377397Phase 31 country
- The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in InfantsRecruitingNCT07716813Not applicable1 country
- The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm InfantsNot yet recruitingNCT07896824Not applicable
- Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover TrialNot yet recruitingNCT07895654Not applicable1 country
- Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)RecruitingNCT07894380Not applicable1 country
- Impact of Higher Zinc Supplementation on Neonatal Weight VelocityRecruitingNCT07896070Phase 41 country
- Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized TrialRecruitingNCT06420531Not applicable1 country
- The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.RecruitingNCT07787845Not applicable1 country
- The Correlation Between Red Cell Transfusion and Complications of PrematurityRecruitingNCT071239481 country
- The Impact of Music Medicine on Preterm Brain Development and BehaviorRecruitingNCT06536296Not applicable1 country
- Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream InfectionsRecruitingNCT066561041 country
- Cervical Stiffness in Women With Threatened Preterm LaborRecruitingNCT078402351 country
- Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate RiskNot yet recruitingNCT07878819Not applicable1 country
- Efficacy of a Video-based, Parent-centered Home Developmental Intervention for Infants at High Risk for Developmental Delay: a Multicenter Randomized Controlled TrialNot yet recruitingNCT07882199Not applicable
- Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding OutcomesNot yet recruitingNCT07883707Not applicable
- Imaging Retinal Vasculature in Infant EyesRecruitingNCT055580591 country
- Music Intervention for Preterm BirthRecruitingNCT05945264Not applicable1 country
- Effect of Automated Oxygen Control on Early-childhood Lung MechanicsNot yet recruitingNCT078668201 country
- Elevated Midline Positioning During Diaper Change in Preterm InfantsNot yet recruitingNCT07865897Not applicable
- Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature NeonatesRecruitingNCT06849596Not applicable3 countries
- nCPAP Versus High-Flow Nasal Cannula in Preterm Infants With RDSNot yet recruitingNCT07869719Not applicable
- NICU-to-Home Dyadic Support for Very Preterm Infants and FamiliesNot yet recruitingNCT07820462Not applicable1 country
- eCPAP Follow-up at School AgeNot yet recruitingNCT07860931