Interventions for Premature Infants

Recruiting at 52 trial locations

Overseen By Matthew A Rysavy, MD, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Gestational age outside 22-23 weeks

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather information on the outcomes and care practices for babies born extremely early, specifically those delivered between 22 and 23 weeks of pregnancy. By collecting data from several hospitals, the researchers hope to better understand how these tiny babies are cared for and how they fare over time. This trial might be relevant for those expecting a baby around this very early stage or if a tiny newborn has been admitted to intensive care. The study seeks cases involving births or NICU admissions at this gestational age range.

As an unphased trial, participation can help improve care practices for future premature births.

Why are researchers excited about this trial?

Researchers are excited about the Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset trial because it aims to create a streamlined and comprehensive dataset to improve neonatal and perinatal care. Unlike existing treatment approaches that rely on varied and sometimes inconsistent data, this trial seeks to establish a standardized method for collecting and analyzing crucial health information. This could lead to more precise and effective interventions for newborns, enhancing their chances of healthier outcomes. By integrating data from multiple sites, the trial has the potential to uncover patterns and insights that individual studies might miss, offering a broader understanding of what works best for neonatal care.

Who Is on the Research Team?

Matthew A Rysavy, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

Inclusion Criteria

All local births with gestational ages of 22 weeks 0 days - 23 weeks 6 days, regardless of pregnancy outcome or neonatal intensive care (NICU) admission;

All outborn NICU admissions with gestational age at birth of 22 weeks 0 days - 23 weeks 6 days

Optional: Centers who desire to include data for NICU admissions of infants born <22 weeks' gestation may also submit these data

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Observational baseline data on mothers and infants are collected, including demographics, health, labor, delivery, medical interventions, and clinical outcomes.

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Saitama Medical University

Collaborator

Trials

11

Recruited

5,700+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Jichi Medical University

Collaborator

Trials

13

Recruited

8,000+