Care Coordination for Premature Birth

Overseen By Hadassah Colbert

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Sterilization, Moving, Limited English, Organ failure, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Care Coordination after Preterm Birth (CCAPB), designed to assist women who have had premature babies. The program guides these women through healthcare systems and encourages them to manage their health actively. Participants will either receive this specialized care or continue with their usual care for comparison. Women who had a preterm birth (before 34 weeks, or 34–36 weeks with specific risk factors) and plan to use certain pediatric care services might be suitable candidates.

As an unphased trial, this study allows participants to contribute to innovative care strategies for women after preterm birth.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this behavioral intervention is safe for premature birth care?

Research shows that coordinating care for pregnant women can be very helpful and safe. Previous studies have found that organizing care during pregnancy can greatly reduce the risk of early delivery for women on Medicaid. Another review found that case management, similar to care coordination, often helps lower preterm birth rates.

The program under discussion, Care Coordination After Preterm Birth (CCAPB), is based on these types of interventions. Although the specific study on CCAPB doesn't provide detailed safety information, research on similar programs suggests they are generally safe and don't pose major risks. Since this program focuses on helping families navigate healthcare and stay motivated, and doesn't involve medication, it is not expected to cause the side effects that drugs might. Overall, this approach seems to be a safe way to help families manage healthcare after a premature birth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Care Coordination after Preterm Birth (CCAPB) approach because it focuses on personalized care navigation and motivational enhancement, which is quite different from the usual care options. Unlike standard treatments that primarily address immediate medical needs, CCAPB emphasizes guiding families through the complex healthcare system and motivating them to engage actively in the care process. This holistic approach could potentially improve long-term health outcomes for premature infants by ensuring families receive comprehensive support and are empowered to make informed healthcare decisions.

What evidence suggests that Care Coordination after Preterm Birth (CCAPB) is effective for premature birth?

This trial will compare Care Coordination after Preterm Birth (CCAPB) with usual care. Research has shown that coordinating care during pregnancy can significantly reduce the risk of preterm birth. Studies have found that a care manager—someone who assists with healthcare and provides support—can lower the chances of early delivery for women at high risk. This benefit applies to both Black and White women. Programs focusing on prenatal care, especially for women with fewer resources, have successfully reduced early birth rates. Overall, evidence suggests that organized care and support during pregnancy can lead to better outcomes for babies at risk of premature birth. ^{1 3 5 6 7}

Who Is on the Research Team?

Emily Gregory, MD, MPH

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for females aged 14-45 with a history of preterm birth, intending to seek pediatric care at specific sites and have Medicaid. They must not plan to move or transfer care within six months, have limited English proficiency, a history of sterilization, organ failure or cancer.

Inclusion Criteria

I am between 14 and 45 years old.

History of preterm birth (< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization, tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs)

I am female.

Exclusion Criteria

I have had organ failure or other cancers in the past.

Limited English proficiency

History of sterilization procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Care Coordination After Preterm Birth (CCAPB) intervention focused on health care navigation and motivational enhancement

up to 6 months

Follow-up

Participants are monitored for acceptability and feasibility of the intervention and study procedures

up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Care Coordination after Preterm Birth (CCAPB)

Trial Overview The study tests the Care Coordination After Preterm Birth (CCAPB) program in a small-scale randomized controlled trial to see if it's practical and can be implemented widely. Participants will be assessed before and after the intervention.

How Is the Trial Designed?

Group I: CCAPB (intervention) Experimental Treatment 1 Intervention

Intervention participants will receive an intervention focused on health care navigation and motivational enhancement.

Group II: Usual Care Placebo Group 1 Intervention

Usual care participants will not receive the intervention.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Advances in neonatal care have improved survival rates for premature infants, but these infants still face higher risks of health issues and require thorough follow-up care after hospital discharge.

Pediatric nurse practitioners play a crucial role in the general follow-up of premature infants, ensuring they receive appropriate care and referrals to specialists as needed to address the unique challenges associated with prematurity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive primary care follow-up for premature infants. McCourt, MF., Griffin, CM.[2005]

A survey of 43 follow-up programs for high-risk infants revealed that most programs had to change their clinical assessments due to the COVID-19 pandemic, which they felt compromised their ability to meet the medical and developmental needs of these infants.

Despite the challenges, there was a significant increase in the use of telemedicine, which many programs found improved their connection with families, indicating a potential shift in how follow-up care can be delivered effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-through care for high-risk infants during the COVID-19 pandemic: lessons learned from the Vermont Oxford Network. Litt, JS., Mercier, CE., Edwards, EM., et al.[2022]

Antenatal steroid administration rates before preterm delivery significantly increased from 76% in 1998 to 86% in 2001 across 25 participating centers, demonstrating improved adherence to recommended practices.

By 2001, 23 out of 25 hospitals surpassed the baseline lower-quartile cutoff of 69.3%, indicating that regional collaborations can effectively enhance the quality of perinatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting antenatal steroid use for fetal maturation: results from the California Perinatal Quality Care Collaborative. Wirtschafter, DD., Danielsen, BH., Main, EK., et al.[2007]

Women who received prenatal care coordination had significantly more prenatal visits (10 visits) compared to those who did not participate in the program (8 visits), indicating improved access to prenatal services.

Although care coordination increased WIC participation and reduced smoking rates during pregnancy, it did not show a direct impact on birth outcomes such as birth weight or preterm labor rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of prenatal care coordination on birth outcome. Garry, MF., Brown, HL., Abernathy, MP., et al.[2020]

In a study of 636 extremely preterm infants born in Norway, survival rates improved significantly with increasing gestational age (GA), with only 0% survival for infants born at <23 weeks compared to 82% for those born at 27 weeks.

For survivors, the need for intensive care decreased as GA increased, with a notable reduction in days of mechanical ventilation and oxygen dependency, indicating improved outcomes for more mature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early death, morbidity, and need of treatment among extremely premature infants. Markestad, T., Kaaresen, PI., Rønnestad, A., et al.[2022]

The article emphasizes the importance of a structured discharge and follow-up plan for low birth weight and premature infants to enhance their care and outcomes after intensive care.

Establishing a well-organized plan is crucial due to the increased intensive care these vulnerable infants receive, ensuring they continue to receive appropriate medical attention post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal discharge and follow up. Manzar, S.[2017]

The implementation of guidelines for treating preterm infants from 24 weeks gestation has led to a high survival rate of 43% at 24 weeks and 61% at 25 weeks, indicating improved outcomes for extremely preterm infants in Dutch perinatal centers.

Despite the increased survival rates, a significant proportion of infants (79% at 24 weeks and 71% at 25 weeks) experienced short-term health issues, highlighting the challenges and burdens on neonatal care facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Perinatal policy in cases of extreme prematurity; an investigation into the implementation of the guidelines]. de Kluiver, E., Offringa, M., Walther, FJ., et al.[2018]

A survey of 13 out of 17 Neonatal Intensive Care Units (NICUs) in Lombardy, Italy, revealed that all units have follow-up programs for preterm babies, which include essential evaluations like ophthalmological, neurological, cardiac, and audiometric assessments.

The length of follow-up programs varies from 1 to 7 years, and while all NICUs provide clinical reports to families at discharge, only 54% send these reports to the Primary Care Physician, indicating a need for improved communication and standardization across NICUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preterm infant follow-up program in Lombardy Region-- Italy]. Migliori, C., Bellan, C.[2019]

In a study of 2,275 extremely preterm infants born in Canada, 36.8% were re-hospitalized, with significant regional disparities in re-hospitalization rates ranging from 25.9% to 49.4%.

Key risk factors for re-hospitalization included male sex, specific health conditions like bronchopulmonary dysplasia and necrotizing enterocolitis, prolonged NICU stays, and sociodemographic factors such as ethnicity and having siblings at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for re-hospitalization following neonatal discharge of extremely preterm infants in Canada. Puthattayil, ZB., Luu, TM., Beltempo, M., et al.[2022]

In a study of 433,814 preterm infants across 465 US hospitals, moderate and late preterm (MLP) infants received lower quality care in type C NICUs, which are equipped for all surgeries, compared to type A NICUs, indicating that higher complexity does not always equate to better outcomes for this group.

For extremely and very preterm infants, care quality was consistent across different NICU types, suggesting that the level of NICU complexity may not significantly impact their care, highlighting the need for policies that enhance care quality for MLP infants in less complex settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Neonatal Intensive Care Unit Type and Quality of Care in Moderate and Late Preterm Infants. Salazar, EG., Handley, SC., Greenberg, LT., et al.[2023]

The Canadian Preterm Birth Network (CPTBN) aims to improve outcomes for preterm infants by collaborating across 24 maternal-fetal units, 31 neonatal intensive care units, and 26 follow-up programs, creating a comprehensive national cohort.

The CPTBN will focus on quality improvement in healthcare practices, assess the impact of these practices on maternal and neonatal outcomes, and evaluate the effects of preterm birth on families and healthcare resources, ultimately aiming to enhance support for parents and optimize care for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Canadian Preterm Birth Network: a study protocol for improving outcomes for preterm infants and their families. Shah, PS., McDonald, SD., Barrett, J., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4459720/

Effects of Maternity Care Coordination on Pregnancy ... Conclusions. These findings suggest that coordination of care in pregnancy can significantly reduce the risk of preterm delivery among Medicaid-enrolled women.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10215556/

The Effectiveness of Prenatal Care Programs on Reducing ... This review was conducted with the aim to assess the effectiveness of prenatal care programs in reducing PTB in socioeconomically disadvantaged women.

3. smfm.org smfm.org/news/having-a-care-manager-during-pregnancy-reduces-likelihood-of-premature-birth-for-high-risk-patients

Having a Care Manager During Pregnancy Reduces ... When looking simply at the receipt of intensive care management, findings showed that preterm birth rates decreased for both Black and White ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937822001892

The association between care management and neonatal ... This study aimed to examine the association between care-management and birth outcomes (low birthweight and preterm birth rates) among high-risk non-Hispanic ...

5. publications.aap.org publications.aap.org/pediatrics/article/152/1/e2023062511/192156/Primary-Care-Framework-to-Monitor-Preterm-Infants

Primary Care Framework to Monitor Preterm Infants for ... This clinical report links preterm birth and perinatal complications to early childhood developmental disability risks.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36063876/

Limits of prenatal care coordination for improving birth ... Participant data included risks screens for food insecurity, depression, anxiety, pregnancy intention, and intimate partner violence, in addition to clinical ...

7. ajog.org ajog.org/article/S0002-9378(22)00746-3/fulltext

Should case management be considered a component of ... Our review of existing evidence finds consistent reductions or trends toward reductions in preterm birth with case management.