Background Infants in the Neonatal Intensive Care Unit (NICU) benefit most from occupational therapy (OT) and physical therapy (PT) when delivered at high frequencies. However, implementing these recommendations in clinical practice remains challenging. This study will investigate the impact of different therapy care delivery models on extremely preterm infants and their mothers. Methods This pilot study uses a non-randomized comparative cohort design with historical controls. A retrospective cohort of 30 infants will represent usual care therapies (UCT). Two prospective cohorts (n = 30 each) will be enrolled following the launch of a new Small Baby Unit (SBU) at a Level IV NICU. The first prospective group will receive UCT within the SBU (SBU + UCT), while the second will receive an Immersive Therapy Model (SBU + ITM). Mothers of infants in the prospective groups will be invited to participate. The SBU introduces developmentally supportive medical and environmental protocols, with ITM adding structured, high-frequency therapy as well as parent-delivered developmental activities. As a pilot study, primary outcomes include the following: (1) feasibility of ITM implementation, measured by changes in therapy frequency and parent-administered activities and (2) comparisons of infant motor and neurobehavioral outcomes, as well as maternal stress and parenting competence. Secondarily, we will evaluate the preliminary efficacy of the SBU + ITM model on infant motor and neurobehavioral outcomes, as well as maternal stress and sense of competence. Finally, we will explore the ITM’s potential influence on two important drivers of health care costs in the NICU as compared to UCT: (1) time to infant achievement of independent oral feeds and (2) length of hospitalization. Discussion Findings may inform neonatal physical and occupational therapy practices by evaluating a novel care model aimed at improving outcomes for both infants and parents. Given its practical implementation and potential for significant impact, the ITM could represent a paradigm shift in NICU-based therapy care. Trial registration ClinicalTrials.gov, NCT06927037, Registered 16 April 2025, <a href="https://clinicaltrials.gov/study/NCT06927037?intr=Immersive%20Physical%20Therapy&term=preterm%20infant&rank=1">https://clinicaltrials.gov/study/NCT06927037?intr=Immersive%20Physical%20Therapy&term=preterm%20infant&rank=1</a>. Protocol number Version 5, 2/16/2026.

Immersive physical and occupational therapy in the neonatal intensive care unit: a non-randomized comparative cohort trial protocol

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2026年7月3日

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Dana B. McCarty,
Sabrina Zadrozny,
Kathryn Tarnai,
Catherine Ustby,
Meredith Soucie,
Stacey C. Dusing

摘要

Background

Infants in the Neonatal Intensive Care Unit (NICU) benefit most from occupational therapy (OT) and physical therapy (PT) when delivered at high frequencies. However, implementing these recommendations in clinical practice remains challenging. This study will investigate the impact of different therapy care delivery models on extremely preterm infants and their mothers.

Methods

This pilot study uses a non-randomized comparative cohort design with historical controls. A retrospective cohort of 30 infants will represent usual care therapies (UCT). Two prospective cohorts (n = 30 each) will be enrolled following the launch of a new Small Baby Unit (SBU) at a Level IV NICU. The first prospective group will receive UCT within the SBU (SBU + UCT), while the second will receive an Immersive Therapy Model (SBU + ITM). Mothers of infants in the prospective groups will be invited to participate. The SBU introduces developmentally supportive medical and environmental protocols, with ITM adding structured, high-frequency therapy as well as parent-delivered developmental activities. As a pilot study, primary outcomes include the following: (1) feasibility of ITM implementation, measured by changes in therapy frequency and parent-administered activities and (2) comparisons of infant motor and neurobehavioral outcomes, as well as maternal stress and parenting competence. Secondarily, we will evaluate the preliminary efficacy of the SBU + ITM model on infant motor and neurobehavioral outcomes, as well as maternal stress and sense of competence. Finally, we will explore the ITM’s potential influence on two important drivers of health care costs in the NICU as compared to UCT: (1) time to infant achievement of independent oral feeds and (2) length of hospitalization.

Discussion

Findings may inform neonatal physical and occupational therapy practices by evaluating a novel care model aimed at improving outcomes for both infants and parents. Given its practical implementation and potential for significant impact, the ITM could represent a paradigm shift in NICU-based therapy care.

Trial registration

ClinicalTrials.gov, NCT06927037, Registered 16 April 2025, https://clinicaltrials.gov/study/NCT06927037?intr=Immersive%20Physical%20Therapy&term=preterm%20infant&rank=1.

Protocol number

Version 5, 2/16/2026.