What side effects are associated with this type of intervention?

Common treatments for preterm birth, such as respiratory support (including mechanical ventilation and continuous positive airway pressure), surfactant therapy, and medications like corticosteroids, can have several side effects. Respiratory support may lead to lung injury or bronchopulmonary dysplasia. Surfactant therapy is generally safe but can occasionally cause airway obstruction or infection. Corticosteroids, used to accelerate lung development, may increase the risk of neurodevelopmental issues and infections. These treatments aim to improve survival and outcomes but come with potential risks that should be discussed with healthcare providers.

What prior FDA approvals exist?

The FDA has approved several treatments for managing preterm birth and improving neonatal outcomes. One notable example is magnesium sulfate, which has been shown to reduce the risk of cerebral palsy when administered antenatally for neuroprotection in preterm infants. Additionally, tocolytics like nifedipine and indomethacin are used to delay labor, although their use is more focused on short-term prolongation of pregnancy rather than long-term outcomes. These treatments align with the goals of the Periviable GOALS Decision Support Tool, which aims to facilitate informed decision-making and values clarification for families facing periviable deliveries.

What other types of research exist?

Promising novel alternatives to the Periviable GOALS Decision Support Tool for preterm birth patients in 2024 include: 1) AI-driven decision support systems that use machine learning to provide personalized risk assessments and treatment recommendations, 2) Mobile health applications that offer interactive decision aids and real-time communication with healthcare providers, 3) Virtual reality (VR) tools that simulate potential outcomes to help parents understand the implications of different treatment options, and 4) Enhanced telemedicine platforms that integrate comprehensive decision support features and facilitate remote consultations with specialists.

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Periviable GOALS DST for Premature Birth

N/A

Recruiting

Led By Brownsyne Tucker Edmonds, MD, MPH, MS

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant between 22 0/7 to 24 6/7 weeks gestation

Presenting to Labor & Delivery at an approved study site with a pregnancy complication that poses the potential threat of or need for periviable delivery (e.g., rupture of membranes, preterm labor, shortened cervix, pre-eclampsia, and growth restriction).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a tool called Periviable GOALS DST, which helps parents of extremely premature babies make informed decisions by providing clear information and helping them clarify their values. It targets pregnant patients at risk of delivering very early.

Who is the study for?

This trial is for adults over 18 who are pregnant between 22 and almost 25 weeks, facing complications that could lead to very early delivery. They should have already discussed neonatal treatment options with their healthcare team and be able to make decisions for the baby.

What is being tested?

The trial tests a decision support tool called Periviable GOALS DST designed to help parents make informed choices about neonatal resuscitation in extremely premature births. It aims to improve shared decision-making and satisfaction with the decisions made.

What are the potential side effects?

Since this intervention is a decision support tool rather than a medical treatment, it does not have physical side effects. However, its impact on emotional or psychological well-being isn't detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 24 weeks pregnant.

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I am pregnant with complications that might lead to an early delivery.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

This trial's timeline: 3 weeks for screening, Varies for treatment, and before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Shared Decision Making

Secondary study objectives

Acceptability of the decision support tool

Anxiety

Decision Control

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Periviable GOALS DST GroupExperimental Treatment1 Intervention

Participants randomized to the intervention will be presented with the Periviable GOALS DST and instructed to review the DST in its entirety. The participant will complete the education and values clarification components of the DST with the Recruitment RA present to confirm completion. Following completion of the GOALS DST, the Recruitment RA will repeat knowledge and decisional conflict instruments and assess acceptability.

Group II: Usual Care (control)Active Control1 Intervention

Participants assigned to this group will proceed with usual medical care and treatment, consisting of counseling by the teams of obstetricians and/or neonatologists at the respective study sites.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for preterm birth include antenatal corticosteroids, which accelerate fetal lung maturation, tocolytics that delay labor, and magnesium sulfate for neuroprotection. These treatments are vital as they enhance survival rates and reduce complications in preterm infants, supporting informed decision-making and optimizing neonatal outcomes, as emphasized in the Periviable GOALS Decision Support Tool.

An Early Collaborative Intervention Focusing on Parent-Infant Interaction in the Neonatal Period. A Descriptive Study of the Developmental Framework.Training attention control of very preterm infants: protocol for a feasibility study of the Attention Control Training (ACT).Olfactive stimulation interventions for managing procedural pain in preterm and full-term neonates: a systematic review protocol.