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Home › Conditions › Preterm Birth

Preterm Birth

Part of Obstetric Labor Complications

24 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Preterm Birth

27 trials tracked for Preterm Birth: 8 in phase 3 or 4 and 5 with published results. The most-cited published study has 824 citations.

27Trials tracked
8Phase 3 & 4
0Recruiting
5With published results
Phase distribution
Phase 4 3 Phase 3 5 Phase 2 2 Other / NA 17
  1. Phase 3 Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Completed · 824 cited
  2. Phase 3 Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery Completed · 233 cited
  3. Phase 4 Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Completed · 58 cited
  4. Phase 4 Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes Completed · 45 cited
  5. Phase 4 Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth Completed · 5 cited
  6. Phase 3 Antenatal Micronutrient Supplementation and Infant Survival Completed
Show 21 more trials
  1. Phase 3 17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies Completed
  2. Phase 3 Oral Progesterone for Prevention of Preterm Birth Completed
  3. Phase 2 Reducing Preterm Births in Underserved Pregnant Women Completed
  4. Phase 2 Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery Completed
  5. N/A Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions Completed
  6. N/A Prenatal Breast Pump Education of Mothers and Their Support Person Completed
  7. N/A Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix Completed
  8. N/A Tennessee Connections for Better Birth Outcomes Completed
  9. N/A Trial of the Use of Antenatal Corticosteroids in Developing Countries Completed
  10. N/A EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan Completed
  11. N/A Prevention of Preterm Birth With a Pessary in Singleton Gestations Completed
  12. N/A Cervix Monitor for Elasticity and Length Measurements Completed
  13. N/A Comparative Effectiveness of Treatment Options for Genital Herpes Infection to Reduce Adverse Pregnancy Outcomes Completed
  14. N/A Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi Completed
  15. N/A Maternal Role in Oral Feed Establishment in Preterm Neonates Completed
  16. N/A Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan Completed
  17. N/A Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences Completed
  18. N/A A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot Completed
  19. N/A The Use of Progesterone to Reduce Preterm Birth Completed
  20. N/A Sustained Aeration of Infant Lungs Trial Completed
  21. N/A Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention Completed

Showing the 27 most-cited and recently-updated of 27 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Preterm Birth: what the trials found

Betamethasone administration significantly improved neonatal outcomes in cases of preterm birth, specifically reducing the number of neonates with severe respiratory complications (p < 0.001) and decreasing the number of neonates requiring immediate resuscitation after birth (p = 0.003) 4.

Hydroxyprogesterone caproate (HPC) was evaluated for its impact on preterm birth; trials recorded counts of births before 35, 32, and 37 weeks gestation 5. Additionally, 17-alpha-hydroxyprogesterone caproate was associated with lower rates of oxygen therapy at 28 days of life and fewer instances of grade 3 or 4 intraventricular hemorrhage 7.

Iron (27 mg) and folic acid (600 ug) supplementation did not show statistically significant differences in infant mortality through 6 months of age (p = 0.36), neonatal mortality (p = 0.78), or post-neonatal mortality (p = 0.11) 6.

Supplementation with Docosahexaenoic Acid and Arachidonic Acid (DHA+AA) resulted in significant changes to erythrocyte fatty acid levels (p < 0.001), though no statistically significant differences were found in infant behavior scores 2. LCPUFA oil supplementation did not show statistically significant impacts on child behavior or fatty acid levels 1.

Recent results — preliminary, needs further review

  • Xylitol gum was associated with a lower rate of preterm birth, fewer infants weighing less than 2500 grams, and fewer cases of adverse neonatal composite morbidity and mortality (all p < 0.05) 17.
  • A silicon ring (Arabin Pessary) was associated with lower rates of spontaneous delivery before 34 weeks and 28 weeks compared to the control group 20.

For the clinician treating this condition

  • Betamethasone is effective in reducing severe respiratory complications and the need for immediate resuscitation in neonates 4.
  • Progesterone-based interventions (HPC) are associated with reduced oxygen therapy requirements and lower rates of intraventricular hemorrhage 7.
  • Iron and folic acid supplementation do not significantly impact neonatal or post-neonatal mortality rates 6.

AI synthesis of 8 cited trials, updated Jun 25, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Preterm birth linked to higher pain intensity and heat pain thresholds in meta-analysis
Pediatrics Meta-analysis
Preterm birth linked to higher pain intensity and heat pain thresholds in meta-analysis Preterm birth may be linked to higher pain levels in adults
This meta-analysis of 731 participants found that individuals born preterm report higher pain intensity and have higher heat pain thresholds…
People born prematurely may experience different sensations of heat and pain as they grow into adulthood.
Frontiers Jul 8, 2026
Topical emollient application improves skin integrity and topical oil reduces sepsis risk in preterm neonates
Pediatrics Meta-analysis
Topical emollient application improves skin integrity and topical oil reduces sepsis risk in preterm neonates Topical Oil May Reduce Sepsis Risk in Preterm Infants
This meta-analysis of 5,586 preterm neonates found that topical emollients significantly improved skin integrity (SMD -1.11). While overall …
Applying topical oils may improve skin health and reduce sepsis risk in preterm babies, according to a review of over 5,000 infants.
Jun 15, 2026
NICU noise levels frequently exceed recommended limits and primarily originate from alarms and respiratory devices
Pediatrics Meta-analysis
NICU noise levels frequently exceed recommended limits and primarily originate from alarms and respiratory devices NICU noise levels often exceed safety limits for preterm infants
This systematic review of 113 studies identifies alarm systems and respiratory support as primary sources of high-level noise in NICUs. Whil…
Most neonatal intensive care units have noise levels much higher than recommended, especially from alarms and breathing equipment.
Frontiers Jun 12, 2026
Interdisciplinary early developmental intervention programs may offer small benefits for selective attention and behavioral problems in preterm children
Pediatrics Meta-analysis
Interdisciplinary early developmental intervention programs may offer small benefits for selective attention and behavioral problems in preterm children Early programs may help some preterm children but not all developmental areas
This systematic review and meta-analysis evaluated interdisciplinary early developmental intervention programs (EI) for children born preter…
A review of 2,315 infants suggests early developmental programs may help attention and behavior, but show little effect on language or schoo…
medRxiv Jun 4, 2026
Meta-analysis shows early kangaroo care reduces mortality in very preterm infants compared to conventional care
Pediatrics Meta-analysis
Meta-analysis shows early kangaroo care reduces mortality in very preterm infants compared to conventional care Early skin-to-skin contact may lower death risk for very preterm babies
This systematic review and meta-analysis evaluated early kangaroo care versus conventional neonatal care in very preterm infants (≤32 weeks)…
A review of trials found that starting skin-to-skin care within 24 hours reduced death risk for very preterm infants, though effects on infe…
May 26, 2026
Individual patient data meta-analysis on preterm birth risk in asymptomatic pregnant individuals with prior spontaneous preterm birth
Radiology & Imaging Meta-analysis
Individual patient data meta-analysis on preterm birth risk in asymptomatic pregnant individuals with prior spontaneous preterm birth Women with prior preterm birth may need less treatment if risk is low
This individual patient data meta-analysis synthesized data from 1316 patients across 7 data sets to assess recurrent spontaneous preterm bi…
A new analysis shows doctors can better predict who needs extra care after a preterm birth while sparing others from unnecessary treatment
May 7, 2026
Systematic review finds uncertain benefit of olfactory stimulation in preterm infants
Neurology Sys. Review
Systematic review finds uncertain benefit of olfactory stimulation in preterm infants Smells May Help Preterm Infants Feed and Breathe Better
This systematic review of 14 trials involving 1087 preterm infants assessed olfactory stimulation with various odors. Evidence was very low …
A review of 14 trials suggests that certain odors, like breast milk or vanilla, may slightly reduce apnea and shorten hospital stays in pret…
Cochrane May 6, 2026
Preterm children aged 0–2 years show lower growth rates and IGF-1 levels compared to full-term peers
Primary Care & Family Medicine Cohort
Preterm children aged 0–2 years show lower growth rates and IGF-1 levels compared to full-term peers Preterm babies grow slower due to biology and environment factors
This cohort study followed preterm children aged 0–2 years and compared them to full-term children.
New research shows biology and environment slow preterm baby growth, giving doctors better tools to help them catch up.
Frontiers Apr 29, 2026
Continuous glucose monitoring in very preterm infants shows low ketones and higher lactate in first week
Pediatrics RCT
Continuous glucose monitoring in very preterm infants shows low ketones and higher lactate in first week Study looks at glucose monitoring and metabolites in very preterm infants
This prespecified substudy of an RCT in 168 very low birth weight infants found consistently low ketone concentrations and higher lactate co…
Very preterm infants show high lactate levels that drop in a week, while ketones stay low with no clear link to blood sugar or insulin treat…
Apr 19, 2026
Closed-loop oxygen control shortens ventilation and oxygen duration in preterm infants in RCT
Pediatrics RCT
Closed-loop oxygen control shortens ventilation and oxygen duration in preterm infants in RCT New Technology Helps Preterm Babies Spend Less Time on Ventilators
This randomized controlled trial in 69 preterm infants compared closed-loop automated oxygen control to manual control.
A smart oxygen system helped preterm babies breathe on their own sooner, cutting ventilator time and reducing lung disease risk.
Apr 19, 2026
Extended Caffeine Therapy Reduces Intermittent Hypoxia Burden in Very Preterm Infants in Randomized Trial
Pediatrics RCT
Extended Caffeine Therapy Reduces Intermittent Hypoxia Burden in Very Preterm Infants in Randomized Trial Giving Caffeine a Longer Ride
This randomized clinical trial enrolled 160 infants <30 weeks + 6 days gestational age to evaluate extended caffeine therapy versus placebo.
Extending caffeine treatment for premature babies until 43 weeks reduced dangerous oxygen drops and lowered inflammation markers.
Apr 19, 2026
Full milk feeds from birth show no difference in hospital stay but lower costs for preterm infants
Pediatrics RCT
Full milk feeds from birth show no difference in hospital stay but lower costs for preterm infants Does feeding preterm babies full milk from birth shorten their hospital stay?
This randomized controlled trial in 2088 preterm infants born at 30+0 to 32+6 weeks' gestation compared full milk feeds from birth to gradua…
Starting full milk feeds from birth for preterm babies costs slightly less but does not shorten hospital stays compared to gradual feeding w…
Apr 19, 2026

Research across Obstetric Labor Complications

Related studies from across the Obstetric Labor Complications family.

Report identifies barriers to donor human milk for very low birthweight infants in NICUs
OB/GYN & Women's Health
Report identifies barriers to donor human milk for very low birthweight infants in NICUs Report examines challenges in providing donor milk to premature infants in NICUs
A report describes barriers to providing donor human milk for very low birthweight infants in U.S.
A new report highlights barriers to giving donor human milk to very low birthweight babies in neonatal intensive care units.
CDC Apr 4, 2026

Questions about Preterm Birth

Is there clear evidence that olfactory stimulation benefits preterm infants based on recent reviews?

No, recent systematic review finds uncertain benefit of olfactory stimulation for preterm infants; evidence is insufficient to recommend routine use.

Full answer →
What do studies say about brain development in very low birth weight preterm infants?

Very low birth weight preterm infants show slower head growth and lower IGF-1 levels in early months, and extended caffeine therapy may reduce brain-harming oxygen dips, but direct brain imaging studies are limited.

Full answer →
How do social factors and placental biology affect pregnancy complications in Black women?

Social factors like racial discrimination and socioeconomic deprivation interact with placental biology, including immune dysregulation, to increase pregnancy complication risks in Black women.

Full answer →
Will feeding my preterm baby full milk from birth lower hospital costs?

Yes, starting full milk feeds from birth may lower hospital costs for preterm infants, though it does not shorten hospital stays.

Full answer →
Do preterm children aged 0 to 2 years grow slower than full-term babies?

Yes, preterm children aged 0 to 2 years grow slower than full-term babies, especially in length, weight, and head circumference during the first months of life.

Full answer →
How does cervical length affect my risk of having another preterm birth?

A shorter cervix in mid-pregnancy strongly raises your risk of another preterm birth, and this risk is partly inherited and linked to your history.

Full answer →
See all 6 questions about Preterm Birth →

All Preterm Birth Articles