A Randomized-Controlled Trial Pilot Study Examining the Neurodevelopmental Effects of a 5-Week M Technique Intervention on Very Preterm Infants

PURPOSE: To systematically test the cumulative effect of the M Technique on infant neurodevelopment in hospitalized very preterm infants. DESIGN: A pilot randomized controlled trial (RCT). SUBJECTS: Twenty very preterm infants (<30 weeks gestation with average birth weights <1000 g) were randomly assigned to nontreatment or treatment groups. The study period began once the infants reached 30 weeks postmenstrual age (PMA). METHODS: Each infant received standard neonatal intensive unit (NICU) care or standard NICU care plus a 7-minute M Technique session, 6 times per week for 5 weeks. Neurobehavioral development (using the NICU Network Neurobehavioral Scale [NNNS]) and growth velocity (difference in infant weight at the beginning and end of protocol) were compared between the 2 groups. Physiologic parameters (heart rate, respiratory rate, and oxygen saturations) and infant behavioral states were measured 5 minutes before, during, and up to 10 minutes postintervention continuously on all infants in the treatment group at 3 different gestational time points (30, 32, and 34 weeks PMA) over the 5-week period. RESULTS: Mann-Whitney U analyses revealed no differences between the 2 groups on all 12 NNNS summary score domains but a difference in growth velocity between the 2 groups (P = 0.005). Repeated-measures analysis of variance revealed significant physiologic differences of mean heart rate, respiratory rate, and SaO(2) (F = 41.116, P < 0.0005) and behavioral states (F = 38.564, P < 0.0005) from baseline to 10 minutes after the M Technique intervention across all 3 time points. State scores decreased from baseline (M = 6.11) to post intervention (M = 1.4) at all 3 time points. CONCLUSIONS: This pilot RCT demonstrates the utility of the M Technique in hospitalized very preterm infants starting at 30 weeks PMA with notable evidence of positive weight, physiological, and behavioral state adaptations. Additional research is needed with a larger, randomized design to determine short-and long-term effects specifically related to neurological outcomes.