Multimodal Intervention for Premature Birth

(PRIME Trial)

Recruiting at 20 trial locations

Overseen By Adrienne Bodner

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sera Prognostics, Inc.

Must not be taking: Progesterone, Heparin, Illicit drugs, others

Disqualifiers: Prior preterm delivery, Major fetal anomaly, others

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

Compensation: Varies

Number of Visits: 1

6500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking progesterone or certain blood thinners like heparin, you may not be eligible to participate.

What data supports the effectiveness of the treatment Multimodal intervention strategy for premature birth?

Research shows that a multisensory intervention for preterm infants, guided by parents, can improve language and motor skills by age 2 to 3. Additionally, a NICU music therapy intervention called Multimodal Neurologic Enhancement has been linked to better developmental outcomes in preterm infants. ^{1 2 3 4 5}

Is the multimodal intervention for premature birth generally safe for humans?

The available research does not provide specific safety data for the multimodal intervention for premature birth, but emphasizes the importance of safety in health interventions and the need for more investigation into adverse events. ^{6 7 8 9 10}

How is the Multimodal intervention strategy treatment for premature birth different from other treatments?

The Multimodal intervention strategy for premature birth is unique because it involves a multisensory approach provided by parents, which has been shown to improve language and motor skills in preterm infants. Unlike standard medical treatments, this approach focuses on sensory and movement experiences to support development, and it actively involves parents in the care process. ^{2 5 11 12 13}

What is the purpose of this trial?

This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.

Research Team

Brian Iriye, MD

Principal Investigator

High Risk Pregnancy Center

Eligibility Criteria

This trial is for pregnant women aged 18 or older, with a single baby and no preterm labor signs. They must be between 18-20 weeks along, have had an ultrasound to check cervical length, and agree to follow the study's procedures. Women can't join if they're allergic to aspirin or peanuts, have certain uterine risk factors like large fibroids or malformations, experienced significant vaginal bleeding after week 13 of pregnancy, tested positive for COVID-19 recently, used illicit drugs during this pregnancy, are in another study at the same time, or have serious chronic diseases.

Inclusion Criteria

I am not showing any signs of early labor and my water hasn't broken.

I have had an ultrasound to check my baby's development and my cervical length.

This is a singleton intrauterine pregnancy

Exclusion Criteria

Singleton gestation reduced from an original multiple gestation via embryonic reduction or vanishing twin

The subject has a planned cesarean section or induction of labor prior to 37 0/7 weeks gestation

The subject has experienced vaginal bleeding after 13 6/7 weeks gestation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Testing

Participants are randomized to either the PTB Prevention arm or the Control arm. Blood samples are collected for PreTRM® testing.

2 weeks

1 visit (in-person)

Intervention

Participants in the PTB Prevention arm receive results and, if high risk, undergo a prespecified intervention protocol. Control arm participants receive standard care.

Duration of pregnancy

Follow-up

Participants and their neonates are monitored through pregnancy, delivery, and until initial hospital discharge. Longer-term outcomes are assessed at 180 days, 1 year, and 3 years.

Up to 3 years

Treatment Details

Interventions

• Multimodal intervention strategy

Trial Overview The trial tests a multimodal intervention strategy aimed at preventing premature birth compared to standard care. It's designed as a prospective (looking forward in time), randomized (participants are randomly assigned) controlled study (one group receives the test intervention; another—the control—does not).

Participant Groups

Group I: PTB Prevention Experimental Treatment 1 Intervention

Approximately 6500 women will be screened, consented, and have the PreTRM® test sample collected. Randomization will occur 1:1 at each site. Those randomized to the PTB Prevention arm will receive the PreTRM® test results. If high risk, women will be consented to take part in the intervention. Those not higher risk will continue on with standard of care.

Group II: Control Active Control 1 Intervention

Approximately 6500 women will be screened, consented, and have the PreTRM® test sample collected. Randomization will occur 1:1 at each site. Those randomized to the Control arm will not receive the PreTRM® test results. Control arm subjects will continue on with standard of care.

Who Is Running the Clinical Trial?

Sera Prognostics, Inc.

Lead Sponsor

Trials

4

Recruited

18,200+

High Risk Pregnancy Center, Las Vegas, Nevada

Collaborator

Trials

1

Recruited

6,500+

Findings from Research

Premature infants showed positive responses to multiple sensory stimulation interventions, with benefits observed both immediately and lasting up to 2 years.

To enhance nursing research on sensory stimulation for premature infants, it is important to establish a theoretical framework, provide detailed descriptions of infant samples and environments, and tailor stimulation methods to preserve the infants' epigenetic integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary research of multimodal stimulation of premature infants: an integrated review of the literature. Mueller, CR.[2005]

A multisensory intervention program guided by parents for preterm infants in the neonatal intensive care unit led to significantly better outcomes in receptive language and fine-motor skills at 2 to 3 years of age, as assessed by the Bayley Scale.

The intervention particularly benefited boys in terms of language skills, while parental stress levels remained unchanged, suggesting that the program can enhance child development without increasing parental stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of a multisensory intervention for preterm infants provided by parents, on developmental abilities and on parental stress levels. Gabis, LV., Hacham-Pilosof, K., Yosef, OB., et al.[2015]

Out of 279 systematic reviews analyzed, only 70.61% considered the impact of interventions/controls on adverse events, while other important effect modifiers like treatment duration (21.15%) and dosage (24.73%) were rarely investigated.

The study highlights a significant gap in current systematic reviews regarding the assessment of effect modifiers on harmful effects, suggesting that methodological guidelines should include these factors to improve the evaluation of safety in healthcare interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation. Zhou, X., Yang, X., Cai, F., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Multimodal Neurologic Enhancement Improves Preterm Infants' Developmental Outcomes: A Longitudinal Pilot Study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Multidisciplinary research of multimodal stimulation of premature infants: an integrated review of the literature. [2005]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Parent-Integrated Interventions to Improve Language Development in Children Born Very Preterm. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

An integrative research review of intervention studies with premature infants from disadvantaged backgrounds. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The influence of a multisensory intervention for preterm infants provided by parents, on developmental abilities and on parental stress levels. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Taking a chance on outcome standardisation: A cross-sectional analysis assessing the uptake of the prevention of preterm birth core outcome set in randomised controlled trials. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Analysis of Neonatal Neurobehavior and Developmental Outcomes Among Preterm Infants. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Development of a clinical pathway for near-term and convalescing premature infants in a Level II nursery. [2006]

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Prevention of preterm delivery: new interventions]. [2006]

10. England pubmed.ncbi.nlm.nih.gov

Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation. [2023]

11. Sweden pubmed.ncbi.nlm.nih.gov

The mother-baby relationship in the event of extreme prematurity: intervention possibilities within a multidisciplinary team. [2005]

12. Brazil pubmed.ncbi.nlm.nih.gov

The effects of multisensory stimulation on the length of hospital stay and weight gain in hospitalized preterm infants: A systematic review with meta-analysis. [2023]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Short-term effects of multimodal stimulation on neuromotor behaviour and neonatal pain among hospitalized preterm infants: A feasibility, non-blinded randomized controlled trial. [2023]