Reading Therapy for Newborn Care

Not currently recruiting at 1 trial location

Overseen By Asha Dash, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Hearing disorder, Developmental disability, Fetal Alcohol Syndrome, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 20 minutes per session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mothers reading aloud affects the physiological responses of both the mother and her newborn in the hospital. The focus is on typically developing infants to determine if live reading offers any health benefits. Mothers delivering at Tulane Lakeside Hospital may qualify if their newborn is in the nursery, at least 34 weeks gestational age, and has no hearing or developmental issues. As an unphased trial, this study provides a unique opportunity to contribute to understanding the potential health benefits of maternal reading for newborns.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this reading therapy is safe for newborns?

Research has shown that reading books to newborns, especially in hospital settings like the NICU (neonatal intensive care unit), is safe for both babies and their parents. Studies have found no negative effects from this practice. In fact, reading to babies can positively impact their language development.

For example, one study found that reading books together in the NICU helps prevent language delays. Another study found that a program encouraging parents to read to their babies was well-received and reported no safety concerns.

Overall, reading to newborns is a safe and well-accepted activity for both the baby and the parent. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about reading therapy for newborn care because it introduces an innovative approach to early childhood development right from the start. Unlike traditional treatments that focus on medical interventions, reading therapy emphasizes cognitive and emotional stimulation through storytelling. This method aims to strengthen the bond between parent and child while supporting language skills and brain development from day one. By potentially improving newborn care outcomes with a simple, non-invasive activity, reading therapy could complement existing medical practices and enhance early developmental support.

What evidence suggests that book reading is effective for newborn care?

Research shows that when parents read books to their babies in neonatal intensive care units (NICUs), it can help the babies develop language skills. One study found that babies who experienced shared book reading with their parents showed less decline in language skills in their first two years. Other studies highlight benefits for both babies and parents during their time in the NICU, such as improved bonding and communication. Additionally, parents from diverse backgrounds have successfully used interactive reading styles, enhancing the reading experience. These findings suggest that reading to newborns may support their development. In this trial, participants will read to their newborns to evaluate its impact on development. ^{6 7 8 9 10}

Who Is on the Research Team?

Meghan Howell, MD, MS

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

This trial is for typically developing newborns, aged 34 weeks or older, admitted to Tulane-Lakeside Hospital Newborn Nursery. Their biological mothers must be able to consent in English and complete surveys. Babies with developmental disabilities, hearing disorders, Fetal Alcohol Syndrome, or not medically cleared are excluded.

Inclusion Criteria

Do not have Fetal Alcohol Syndrome

Do not have a diagnosed developmental disability (i.e. Down Syndrome)

Medically cleared to participate in the study

Exclusion Criteria

Has an identified or potential hearing disorder (i.e, failed hearing screen)

Has diagnosed developmental disability (i.e. Down syndrome)

Has Fetal Alcohol Syndrome

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive reading therapy to examine its effect on the ANS of mother and neonate

20 minutes per session

Daily sessions in the hospital

Follow-up

Participants are monitored for changes in parasympathetic nervous system response and vagal tone

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Book reading

Trial Overview The study investigates the impact of live maternal-infant book reading on the autonomic nervous system (ANS) of both mother and child in a hospital setting. It aims to understand how this activity might benefit typically developing infants physiologically.

How Is the Trial Designed?

Group I: Patient arm Experimental Treatment 1 Intervention

The subject population will be newborn infants admitted to the Newborn Nursery (NN) at Tulane Lakeside Hospital. The investigators are anticipating some mothers can be recruited from the prenatal clinics who expect to deliver at Tulane Hospital during pregnancy as well.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Saul's Light Foundation

Collaborator

Trials

1

Recruited

1+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9510730/

A narrative review of the effect of parent–child shared reading ... One study showed that parental shared book reading in an NICU is associated with lower decline in language development during the first 24 months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11884721/

Promoting language and literacy through shared book reading ... The evidence from this scoping review shows the benefits of shared reading for infants and their caregivers during their NICU stay.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05004857

NCT05004857 | The Effect of Reading Therapy on Newborns The investigators will examine the association of reading therapy with the infant's crying patterns, length of stay in the hospital, weight gain, and behavior ...

4. pubs.asha.org pubs.asha.org/doi/10.1044/2020_JSLHR-19-00288

The Impact of Interactive Shared Book Reading on ... This randomized controlled trial showed that caregivers from all socioeconomic backgrounds successfully adopted an interactive shared reading style.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/icd.2465

Mother–infant shared book reading in the first year of life - Ho This study examined verbal and non-verbal features of mother–infant shared book reading in Australia during the first year of life

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3043459/

Using Baby Books to Increase New Mothers' Safety Practices While this 3-group randomized study found educational baby books to be effective for increasing low-income primiparous women's safety practices, these findings ...

7. mdpi.com mdpi.com/1660-4601/18/21/11361

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.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34769878/

Parental Book-Reading to Preterm Born Infants in NICU Background: After preterm birth, infants are at high risk for delays in language development. A promising intervention to reduce this risk ...

9. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.860391/full

A narrative review of the effect of parent–child shared ... One study showed that parental shared book reading in an NICU is associated with lower decline in language development during the first 24 ...

10. researchgate.net researchgate.net/publication/323138896_Implementation_of_a_pilot_program_of_Reach_Out_and_ReadR_in_the_neonatal_intensive_care_unit_a_quality_improvement_initiative

(PDF) Implementation of a pilot program of Reach Out and ... Conclusion: We launched a well-received pilot ROR program in the NICU and reached our goal of ≥50% infants being read to by their parents.