AIM: To synthesize the existing literature and determine the efficacy of neonatal therapy, starting in the neonatal intensive care unit (NICU), on the motor, cognitive, and behavioral outcomes of infants born preterm. METHOD: Databases were searched for randomized controlled trials or quasi-randomized controlled trials of direct therapy early intervention for infants with a gestational age of less than 37 weeks, initiated in the NICU and delivered by a therapist or parent with therapist support. Quality was evaluated using the Cochrane standardized risk of bias assessment tool. Recommendations were made using the Grading of Recommendations, Assessment, Development and Evaluations approach. RESULTS: Fifteen studies met the inclusion criteria. Studies were categorized into four intervention categories: (1) parent-delivered motor intervention (PDMI); (2) therapist-delivered postural control intervention (TDPCI); (3) developmental care; and (4) oromotor intervention. Risk of bias varied from low (10 studies) to high (three studies) or was unclear (two studies). INTERPRETATION: Preliminary support indicates that daily PDMI improves motor and cognitive outcomes in the short-term and possibly long-term. TDPCI is effective in promoting short-term gains in motor development. Developmental care programs designed by a neonatal therapist appear to be effective in improving short-term behavior but are inconclusive for motor and cognitive outcomes or long-term behavioral outcomes. Regarding oromotor interventions, there is insufficient research to be confident in their efficacy on improving developmental outcomes.

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