Cognitive Training for Premature Infant Development

(IMPACT Trial)

Overseen By Kimberly M Armstead

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: 12

Duration: 12 months

188 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.

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 data supports the effectiveness of the treatment Bookworm reading intervention training for premature infant development?

Research shows that early auditory experiences, like reading aloud in the NICU, can enhance language and cognitive development in infants. Additionally, interventions that involve parents, such as the COPE program, have been shown to improve cognitive outcomes in premature infants. ^{1 2 3 4 5}

Is the Bookworm reading intervention safe for use in preterm infants?

Preliminary evidence suggests that shared book reading interventions in the NICU are feasible, well accepted, and may have positive effects on preterm infants' physiological parameters and cognitive development. However, more structured clinical trials are needed to confirm these findings. ^{3 4 6 7 8}

How does the Finger puppet treatment for premature infant development differ from other treatments?

The Finger puppet treatment is unique because it uses a playful, interactive approach to engage premature infants in cognitive training, potentially enhancing their attention control and cognitive development. Unlike other treatments that may focus on medication or passive interventions, this method actively involves infants in a stimulating activity, which could leverage their natural neural plasticity for better developmental outcomes. ^{4 9 10 11 12}

Research Team

Colm P Travers, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for preterm infants born at UAB, delivered before 34 weeks' gestation, currently aged between 32-39 weeks post-menstrual age (PMA), not on sedatives or invasive respiratory support. It aims to help with their development.

Inclusion Criteria

I was born at UAB before 34 weeks, am now 32-39 weeks old, not on sedatives or breathing support.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers of infants receive finger-puppets and training for infant communication, with routine EDI care including Bookworm training

12 months

Regular visits for training and assessment

Follow-up

Participants are monitored for developmental outcomes using ASQ and BSID-IV scores

24 months

Periodic assessments at 12 and 24 months corrected age

Treatment Details

Interventions

• Bookworm reading intervention training
• Finger puppet

Trial Overview The study tests if using finger puppets for joint attention and communication along with routine early developmental intervention (EDI) care and Bookworm reading training boosts cognitive scores at 12 months corrected age compared to just routine EDI and Bookworm training.

Participant Groups

Group I: Caregiver-implemented early developmental intervention (EDI) using finger puppets Experimental Treatment 2 Interventions

Caregivers of infants in the intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.

Group II: Routine EDI care including Bookworm training Active Control 1 Intervention

All study participants will receive Bookworm reading intervention training and routine EDI care.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

The COPE intervention program significantly improved cognitive development in low-birth-weight premature infants, with COPE infants scoring 100.3 compared to 93.9 for comparison infants at 3 months, and a 14-point advantage at 6 months.

Mothers participating in the COPE program reported lower stress levels related to the NICU environment and had a better understanding of their infants' needs, suggesting that the program also positively impacted maternal coping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving cognitive development of low-birth-weight premature infants with the COPE program: a pilot study of the benefit of early NICU intervention with mothers. Melnyk, BM., Alpert-Gillis, L., Feinstein, NF., et al.[2022]

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]

A pilot study involving 82 pre-term infants tested the feasibility of Creative Music Therapy (CMT) to improve neurodevelopmental outcomes, but no significant benefits or adverse effects were found in standard clinical measures at 2 years of age.

The study suggests the need for larger trials and longer follow-up periods to explore potential long-term effects of music therapy on more sensitive developmental outcomes like executive function and social-emotional development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creative Music Therapy and Neurodevelopmental Outcomes in Pre-term Infants at 2 Years: A Randomized Controlled Pilot Trial. Haslbeck, FB., Bucher, HU., Bassler, D., et al.[2021]

Early auditory experiences, such as reading aloud in the NICU, significantly enhance language, cognitive, and social-emotional development in high-risk infants.

Implementing a reading-aloud enrichment program in the NICU can strengthen parent-infant relationships and provide a roadmap for improving neurodevelopmental outcomes in these vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reading Aloud with Infants in the Neonatal Intensive Care Unit: A Unit-Based Program to Enhance Language Enrichment and Support Early Foundational Relationships. Erdei, C., Klass, P., Inder, TE.[2023]

Tactile and kinesthetic stimulation in preterm infants led to trends of shorter hospital stays, increased daily weight gain, and improved self-regulated behaviors compared to a control group of infants who received no intervention.

The study, involving 32 preterm infants, demonstrated that stimulation positively influenced motor control and behavioral adjustments, suggesting that such interventions can enhance clinical outcomes for preterm neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral analysis of preterm neonates included in a tactile and kinesthetic stimulation program during hospitalization. Ferreira, AM., Bergamasco, NH.[2013]

The intervention tested on clinically stable preterm infants (33-34 weeks postconceptional age) over a 4-day period was found to be safe, with physiological parameters like pulse rate and oxygen saturation remaining within normal limits.

The intervention significantly improved the infants' behavioral state, leading to increased alertness, indicating its potential to positively influence developmental outcomes in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of physiologic and behavioral response of intermediate care preterm infants to intervention. White-Traut, RC., Nelson, MN., Silvestri, JM., et al.[2007]

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]

Very preterm infants face a significant risk of neurodevelopmental impairments, with about 10% developing severe disabilities like cerebral palsy or mental retardation.

Around 40% of these infants require special therapies such as psychological, physiotherapy, and speech therapy, highlighting the need for tailored medical and social support to improve their developmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neurological consequences of prematurity]. Zupan-Simunek, V.[2012]

The Attention Control Training (ACT) intervention was successfully delivered to 12 very premature infants, with 83% completing the study, indicating its feasibility for this vulnerable population.

Infants showed engagement in the training, completing an average of 84 minutes over three visits, and demonstrated improved performance, suggesting that ACT may help enhance attention control in very preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very preterm infants engage in an intervention to train their control of attention: results from the feasibility study of the Attention Control Training (ACT) randomised trial. Perra, O., Wass, S., McNulty, A., et al.[2021]

The study aims to assess the feasibility of an eye-tracking cognitive training program, Attention Control Training (ACT), for very preterm infants (born between 28 and 32 weeks gestation) at 12 months of age, focusing on their attention and social attention skills.

This feasibility study will help identify challenges in recruiting and retaining very preterm infants for early cognitive interventions, which are crucial for supporting their developing executive functions and addressing potential cognitive deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training attention control of very preterm infants: protocol for a feasibility study of the Attention Control Training (ACT). Perra, O., Wass, S., McNulty, A., et al.[2022]

The EPIREMED study aims to assess the long-term effects of the Cogmed cognitive training program on visuospatial processing in very preterm children, involving 166 participants aged 5½ to 6 years over an 18-month period.

The study seeks to demonstrate that early cognitive training can improve working memory and overall neuropsychological development, potentially leading to better learning outcomes and reduced behavioral issues in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory deficit. Gire, C., Beltran Anzola, A., Kaminski, M., et al.[2021]

In a study of 83 very preterm infants and 46 full-term infants, focused attention during exploratory play was linked to cognitive development, as measured by the Bayley Mental Development Index (MDI), particularly in infants born before 29 weeks gestational age.

For extremely preterm infants, factors such as fewer days on mechanical ventilation and greater heart rate deceleration during focused attention were significant predictors of cognitive outcomes, highlighting the importance of attention and physiological responses in early cognitive development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focused attention, heart rate deceleration, and cognitive development in preterm and full-term infants. Petrie Thomas, JH., Whitfield, MF., Oberlander, TF., et al.[2021]

References

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

Improving cognitive development of low-birth-weight premature infants with the COPE program: a pilot study of the benefit of early NICU intervention with mothers. [2022]

2. United States 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. [2023]

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

Creative Music Therapy and Neurodevelopmental Outcomes in Pre-term Infants at 2 Years: A Randomized Controlled Pilot Trial. [2021]

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

Reading Aloud with Infants in the Neonatal Intensive Care Unit: A Unit-Based Program to Enhance Language Enrichment and Support Early Foundational Relationships. [2023]

5. Brazil pubmed.ncbi.nlm.nih.gov

Behavioral analysis of preterm neonates included in a tactile and kinesthetic stimulation program during hospitalization. [2013]

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

Patterns of physiologic and behavioral response of intermediate care preterm infants to intervention. [2007]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A narrative review of the effect of parent-child shared reading in preterm infants. [2022]

8. France pubmed.ncbi.nlm.nih.gov

[Neurological consequences of prematurity]. [2012]

9. England pubmed.ncbi.nlm.nih.gov

Very preterm infants engage in an intervention to train their control of attention: results from the feasibility study of the Attention Control Training (ACT) randomised trial. [2021]

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

Training attention control of very preterm infants: protocol for a feasibility study of the Attention Control Training (ACT). [2022]

11. England pubmed.ncbi.nlm.nih.gov

A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory deficit. [2021]

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

Focused attention, heart rate deceleration, and cognitive development in preterm and full-term infants. [2021]