Premature Birth

Pipeline Programs

Companies

Clinical Trials

1 recruiting

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

Pediatrix TherapeuticsChina - Shanghai

4 programs

Placement of a Cervical CerclagePhase 31 trial

Betamethasone - ACTIVEPhase 2/31 trial

Vaginal Progesterone gel.Phase 2/31 trial

Blood spot specimens will be drawnN/A1 trial

Active Trials

NCT00675753Terminated258Est. Aug 2009

NCT02469519Completed194Est. Oct 2022

NCT01812239Withdrawn0Est. Aug 2018

+1 more trials

Sharp TherapeuticsPA - Pittsburgh

1 program

AmpicillinPhase 31 trial

Active Trials

NCT05977400Not Yet Recruiting802Est. Mar 2029

Human BioSciencesWV - Martinsburg

10 programs

Brain TrainingN/A1 trial

Diffuse Correlation SpectroscopyN/A1 trial

H-HOPEN/A1 trial

Language TreatmentN/A1 trial

+5 more programs

Active Trials

NCT02588391Completed57Est. Dec 2018

NCT04367181Completed100Est. May 2023

NCT02041923Completed198Est. Jun 2013

+7 more trials

MedtronicNJ - Phillipsburg

1 program

Adhesive and non-adhesive oximetry sensorsN/A1 trial

Active Trials

NCT00179972Terminated32Est. May 2010

EppendorfGermany - Hamburg

1 program

Arabin Cervical PessaryN/A1 trial

Active Trials

NCT01334489Terminated352Est. Jun 2020

Hamilton medicalSwitzerland - Bonaduz

1 program

Family Integrated CareN/A1 trial

Active Trials

NCT01852695Unknown720Est. Mar 2017

Shield TherapeuticsMA - Wellesley

1 program

Group 1: Standard of CareN/A1 trial

Active Trials

NCT04480255Completed413Est. Jul 2025

ChiesiBrazil - Santana de Parnaíba

1 program

LONG LOVE FrameworkN/A1 trial

Active Trials

NCT05618769Unknown330Est. Jul 2025

Trace BiosciencesOR - Beaverton

1 program

Web ApplicationN/A1 trial

Active Trials

NCT03232190Unknown180Est. Dec 2022

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

2028

2029

Sharp TherapeuticsAmpicillin

Pediatrix TherapeuticsPlacement of a Cervical Cerclage

Pediatrix TherapeuticsBetamethasone - ACTIVE

Pediatrix TherapeuticsVaginal Progesterone gel.

ChiesiLONG LOVE Framework

Human BioSciencesPALS intervention condition

Shield TherapeuticsGroup 1: Standard of Care

Human BioSciencesPreemie Prep for Parents

Human BioSciencesLanguage Treatment

Human BioSciencesDiffuse Correlation Spectroscopy

Human BioSciencesLanguage Treatment

Human BioSciencesBrain Training

Human BioSciencesPopulation PK/PD of Off Label Drugs in Premature Neonates

Trace BiosciencesWeb Application

Hamilton medicalFamily Integrated Care

Showing 15 of 21 trials with date data

Clinical Trials (21)

Total enrollment: 4,723 patients across 21 trials

NCT05977400 Sharp TherapeuticsAmpicillin

NICU Antibiotics and Outcomes (NANO) Follow-up Study

Start: Apr 2024Est. completion: Mar 2029802 patients

Phase 3Not Yet Recruiting

NCT01442207 Pediatrix TherapeuticsPlacement of a Cervical Cerclage

Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

Start: Mar 2012Est. completion: May 20130

Phase 3Withdrawn

NCT02469519 Pediatrix TherapeuticsBetamethasone - ACTIVE

Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes

Start: Mar 2016Est. completion: Oct 2022194 patients

Phase 2/3Completed

NCT01812239 Pediatrix TherapeuticsVaginal Progesterone gel.

Vaginal Progesterone in Twins With Short Cervix

Start: Mar 2014Est. completion: Aug 20180

Phase 2/3Withdrawn

NCT05618769 ChiesiLONG LOVE Framework

Towards Life-Long Healthy Lungs: A Multidisciplinary Follow-up Framework for Preterm Infants

Start: Jul 2022Est. completion: Jul 2025330 patients

N/AUnknown

NCT04856501 Human BioSciencesPALS intervention condition

A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm

Start: Aug 2020Est. completion: Jun 2025300 patients

N/ARecruiting

NCT04480255 Shield TherapeuticsGroup 1: Standard of Care

NICU2HOME+: Supporting Illinois Families

Start: Aug 2020Est. completion: Jul 2025413 patients

N/ACompleted

NCT04093492 Human BioSciencesPreemie Prep for Parents

Preemie Prep For Parents (P3): Home Antenatal Prematurity Education

Start: Feb 2020Est. completion: Jan 2022175 patients

N/ACompleted

NCT04193579 Human BioSciencesLanguage Treatment

Listening to Mom 2: Neural, Clinical and Language Outcomes

Start: Nov 2019Est. completion: Apr 202557 patients

N/ACompleted

NCT04367181 Human BioSciencesDiffuse Correlation Spectroscopy

DCS Study in Extremely Premature Newborns

Start: Mar 2019Est. completion: May 2023100 patients

N/ACompleted

NCT02847689 Human BioSciencesLanguage Treatment

Listening to Mom in the NICU: Neural, Clinical and Language Outcomes

Start: Jul 2016Est. completion: Oct 202146 patients

N/ACompleted

NCT02588391 Human BioSciencesBrain Training

Brain Training in Preterm Children at Risk for Inattention, Hyperactivity, and Executive Function Impairment

Start: Oct 2015Est. completion: Dec 201857 patients

N/ACompleted

NCT02421068 Human BioSciencesPopulation PK/PD of Off Label Drugs in Premature Neonates

Population PK/PD of Off Label Drugs in Premature Neonates

Start: Aug 2014Est. completion: Jun 2017246 patients

N/ACompleted

NCT03232190 Trace BiosciencesWeb Application

The Use of an Age-linked App for Parents During and After a NICU Stay

Start: Jan 2014Est. completion: Dec 2022180 patients

N/AUnknown

NCT01852695 Hamilton medicalFamily Integrated Care

Family Integrated Care in the NICU

Start: Mar 2013Est. completion: Mar 2017720 patients

N/AUnknown

NCT01334489 EppendorfArabin Cervical Pessary

The Trial of Pessary After Laser for TTTS

Start: Dec 2012Est. completion: Jun 2020352 patients

N/ATerminated

NCT00675753 Pediatrix TherapeuticsBlood spot specimens will be drawn

Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families

Start: Sep 2008Est. completion: Aug 2009258 patients

N/ATerminated

NCT02041923 Human BioSciencesH-HOPE

Feeding and Transition to Home for Preterms at Social Risk

Start: Jan 2007Est. completion: Jun 2013198 patients

N/ACompleted

NCT00179972 MedtronicAdhesive and non-adhesive oximetry sensors

Evaluation of Pulse Oximetry Sensors in Neonates

Start: Sep 2005Est. completion: May 201032 patients

N/ATerminated

NCT00056680 Human BioSciencesPsychoeducational video

Three-Part Program for Parents With Premature Infants

Start: Jul 2001Est. completion: Dec 2006173 patients

N/ACompleted

NCT00065364 Human BioSciencesNewborn Individualized Developmental Care Assessment Program

Improving Brain Development in Medically Healthy Premature Infants

Start: May 200090 patients

N/ACompleted

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals

1 actively recruiting trials targeting 4,723 patients

10 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.