Data from: Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial

<p><b>Objective: </b>To evaluate the effect of an oral stimulation program in preterm on the performance in the first oral feeding, oral feeding skills and transition time from tube to total oral intake.</p> <p><b>Study Designer: </b>Double-blind randomized clinical trial including very preterm newborns. Congenital malformations, intracranial hemorrhage grade III or IV, bronchopulmonary dysplasia, and necrotizing enterocolitis were excluded. Intervention group (GI) received an oral stimulation program of tactile extra-, peri-, and intraoral tactile manipulation once a day for 15 minutes, during a 10-day period. Control group (GII) received sham procedure with same duration of time. Feeding ability was assessed by a speech-language pathologist blinded to group assignment. The classification of infants' oral performance was determined by Oral Feeding Skills (OFS). Neonates were monitored until hospital discharge.</p> <p><b>Results: </b>Seventy-four (37 in each group) were randomized. Mean gestational ages and birth weights were 30±1.4 and 30±1.5 weeks, and 1,452±330g and 1,457±353g for intervention and control groups, respectively. Mean proficiency (PRO), transfer rate (RT), and overall transfer (OT) were 41.5%±18.3 and 19.9%±11.6 (p&lt;0.001), 2.3 mL/min and 1.1 mL/min (p&lt;0.001), 57.2%±19.7 and 35.0%±15.7 (p&lt;0.001) in intervention and control groups, respectively. Median transition time from tube to oral feeding was 4 (3-11) and 8  days in intervention and control groups, respectively (p=0.003). Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p&lt;0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p=0.007, HR 1.97, 95%CI 1.2-3.2).</p> <p><b>Conclusion: </b>Infants who were breast-fed and an oral stimulation program proved beneficial in reducing transition time from tube feeding to oral feeding.</p> <p>ClinicalTrials.gov number NCT03025815</p>