Early Literacy Program for Preterm Infants

(BUILD Trial)

Overseen By Colm Travers

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Major malformation, Known syndrome, others

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

Compensation: Varies

Number of Visits: 3

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an early literacy and developmental program can boost developmental test scores at 24 months for preterm infants. Caregivers will learn to engage in shared reading with their infants, and some will receive additional training in a more comprehensive literacy and numeracy program. Babies born at UAB, at more than 35 weeks, and set to go home after the initial hospital stay may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding early childhood development and potentially benefit a child's growth.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this early literacy program is safe for preterm infants?

Research shows that reading with young children aids the development of their language, thinking, and social skills. Many studies have demonstrated these benefits. Other early intervention methods, such as the SAFE method, have improved infants' movement and sensory skills. These approaches have received positive feedback and have enhanced home environments.

Although this early reading program for preterm infants is new, past studies suggest that similar methods are safe and well-accepted. Since the study involves a non-drug approach, it generally poses less risk than medical treatments. Overall, the program aims to support development safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Early Literacy Program for preterm infants because it combines a coach-led, caregiver-implemented approach with traditional Reach Out and Read training. Unlike typical programs that may solely rely on book distribution during well-child visits, this intervention emphasizes active caregiver involvement and personalized guidance, potentially enhancing developmental outcomes. This method leverages the unique bond between caregivers and infants, aiming to foster language and cognitive skills more effectively from an early age.

What evidence suggests that this early literacy program is effective for increasing developmental test scores in preterm infants?

Research shows that reading with young children can greatly aid the development of their language and thinking skills. In this trial, participants will join one of two treatment arms. One arm will receive the "Reach Out and Read plus intervention," which includes Reach Out and Read Training along with a coach-led, caregiver-implemented early literacy and developmental program. The other arm will receive "Reach Out and Read only" during well-child visits. Previous studies have found that early programs led by coaches helped preterm infants without brain injuries learn skills more effectively. Another study showed that reading to preterm infants in the NICU (Neonatal Intensive Care Unit) improved their language development in their first two years. These findings suggest that adding a structured reading program can enhance the development of preterm infants. Therefore, this approach might benefit the growth and development of preterm infants during their early years. ^{1 3 6 7 8}

Who Is on the Research Team?

Colm P Travers, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for caregivers of preterm infants and neonates. It aims to include those who are willing to participate in early literacy and developmental programs, with the goal of improving their child's development by age 24 months.

Inclusion Criteria

Inborn at UAB

Delivered at more than 35 weeks' gestation

I am expected to go home after my first hospital stay.

Exclusion Criteria

Presence of a known syndrome

Enrolled in a competing study

My family primarily speaks a language other than English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers receive shared reading training, with half receiving additional coach-led early literacy and developmental program

24 months

Regular well-child visits

Follow-up

Participants are monitored for developmental progress and literacy scores

36 months

ASQ-3 assessments at 12, 24, and 36 months; literacy assessments at 3, 4, and 5 years

Long-term follow-up

Assessment of kindergarten readiness and literacy scores at 60 months

60 months

What Are the Treatments Tested in This Trial?

Interventions

• Coach-led caregiver-implemented early literacy and developmental programming

Trial Overview The study tests if adding a coach-led caregiver-implemented program to shared reading training can boost developmental scores at two years old. Caregivers will either receive just reading training or both reading and the additional program.

How Is the Trial Designed?

Group I: Reach Out and Read plus intervention Experimental Treatment 2 Interventions

Reach Out and Read Training in addition to coach-led caregiver-implemented early literacy and developmental program

Group II: Reach out and Read only Active Control 1 Intervention

Reach Out and Read at well child visits

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

A study involving 284 very preterm infants assessed the effectiveness of a home-based developmental education intervention, but by age 5, there were no significant differences in cognitive, behavioral, or motor outcomes among the intervention groups compared to standard care.

Despite some initial advantages observed at 2 years, the benefits of early intervention did not persist by age 5, raising questions about the long-term efficacy of such programs for improving outcomes in very preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised trial of parental support for families with very preterm children: outcome at 5 years. Johnson, S., Ring, W., Anderson, P., et al.[2019]

A randomized controlled trial involving 95 preterm infants showed that a parent-driven language intervention in the neonatal intensive care unit significantly increased adult word counts and improved language scores at 2 years of age.

The intervention led to an 80% reduction in the odds of having a low language composite score and a 90% reduction in the odds of low receptive language scores, indicating its effectiveness in enhancing language development for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Neonatal Intensive Care Unit Language Intervention for Parents of Preterm Infants and 2-Year Language Outcomes. McGowan, EC., Caskey, M., Tucker, R., et al.[2023]

Shared book-reading interventions in neonatal intensive care units (NICUs) are feasible and well-accepted, providing support for parents and potentially improving language development in preterm infants.

Preliminary evidence suggests that these interventions may lead to better cognitive outcomes, as one study indicated a lower decline in language development for preterm infants who participated in shared reading compared to a historical control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of the effect of parent-child shared reading in preterm infants. Boissel, L., Guilé, JM., Viaux-Savelon, S., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-late-preterm-infant-5-2025-dc0e8

Early Literacy Program for Preterm Infants (BUILD Trial) Trial Overview The study tests if adding a coach-led caregiver-implemented program to shared reading training can boost developmental scores at two years old.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10636377/

Early developmental support for preterm infants based on ... The Explorer Baby early intervention program may be a preferred option to support premature infants without brain injury, as it shows greater skill acquisition ...

3. publications.aap.org publications.aap.org/pediatrics/article/154/6/e2024069091/199468/Literacy-Promotion-An-Essential-Component-of

Literacy Promotion: An Essential Component of Primary ... This technical report reviews the evidence that reading with young children supports language, cognitive, and social-emotional development.

4. eric.ed.gov eric.ed.gov/?q=source%3A%22Journal+of+Early+Intervention%22&pg=8

ERIC - Search Results This study investigated the comparative efficacy of coaching and traditional caregiver instruction on… Descriptors: Family Involvement, ...

5. researchgate.net researchgate.net/publication/356264738_Parental_Book-Reading_to_Preterm_Born_Infants_in_NICU_The_Effects_on_Language_Development_in_the_First_Two_Years

Parental Book-Reading to Preterm Born Infants in NICU This study investigated the possible advantages of book-reading to preterm neonates during their NICU stay on their subsequent language development.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12119034/

Effects of SAFE Early Intervention Approach in the First ... The SAFE early intervention approach enhanced motor and sensory outcomes and provided a more enriched home environment than the NDT‐based home programme.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jpc.70191

Long‐Term Neurodevelopmental Outcomes of the SAFE ... This study aimed to evaluate the effects of the SAFE early intervention approach on cognitive, language, and motor development in infants at ...

8. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-021-02596-1

Protocol for implementation of an evidence based parentally ... Early developmental interventions have the potential to improve outcomes for preterm infants and families. Importantly, early investment in ...