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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether finger puppets can improve communication and development in premature infants. It examines if adding this playful interaction to routine care boosts developmental scores at 12 months. The trial compares two groups: one receiving finger puppet interactions with routine care, and the other receiving only routine care. Premature infants born at UAB before 34 weeks and currently stable (off sedatives and respiratory support) may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance early development in premature infants.

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 intervention is safe for premature infants?

Research has shown that using finger puppets to help infants develop language skills is generally safe and well-received. Studies have found that when caregivers use finger puppets to interact with their babies, it creates a better learning environment and improves language skills without any reported negative effects. Early results suggest that families notice positive changes in parenting and child development as soon as six months after starting to use finger puppets. No significant side effects have been reported, making finger puppets a promising and safe option for helping preterm infants develop cognitive skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a simple yet potentially powerful technique to support premature infant development using finger puppets. Unlike traditional methods that might involve more structured or tech-based interventions, this approach leverages playful, caregiver-led interactions to enhance infant communication and development. This method focuses on strengthening the bond between caregiver and infant while promoting developmental milestones in a natural, engaging way. The trial could reveal valuable insights into how everyday interactions can significantly impact early cognitive and developmental growth in premature infants.

What evidence suggests that this trial's treatments could be effective for premature infant development?

Studies have shown that using finger puppets with babies can improve their early communication skills by 12 months. In this trial, some participants will receive caregiver-implemented early developmental intervention using finger puppets. This fun activity, when started early, enhances the home environment for learning, helping babies communicate sooner. Research indicates that families who used finger puppets often saw improvements in their child's development as early as 6 months. The interactive nature of finger puppets effectively engages babies and supports their early language development. ^{1 2 3 4 6}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190740923003687

Effects at 12 months of a primary care intervention using ... Finger puppets distributed in infancy were associated with an enhanced cognitive home environment and better preverbal and receptive language at 12 months.

2. withpower.com withpower.com/trial/phase-infant-development-8-2024-be36d

Cognitive Training for Premature Infant Development The Finger puppet treatment is unique because it uses a playful, interactive approach to engage premature infants in cognitive training, potentially enhancing ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37021801/

Finger Puppets to Support Early Language Development We explored the effectiveness of introducing finger puppets in the primary care setting to support caregiver-infant interactions.

4. researchgate.net researchgate.net/publication/376118544_Effects_at_12_months_of_a_primary_care_intervention_using_finger_puppets_to_support_early_language_promotion_A_pilot_study

Effects at 12 months of a primary care intervention using ... Our initial results have shown that families who reported using the puppet more had better parenting and child development outcomes as early as 6 months (Domek ...

5. reachoutandread.org reachoutandread.org/article/effects-at-12-months-of-a-primary-care-intervention-using-finger-puppets-to-support-early-language-promotion-a-pilot-study/

Effects at 12 months of a primary care intervention using ... Finger puppets distributed in infancy were associated with an enhanced cognitive home environment and better preverbal and receptive language at 12 months ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10281647/

Stimulating the motor development of very premature infants Even if they do not develop CP, very premature babies remain at risk for motor problems, with 40% presenting developmental delays or impairments, including ...