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

Objective: 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. Study
Designer: 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.
Results: 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<0.001), 2.3 mL/min
and 1.1 mL/min (p<0.001), 57.2%±19.7 and 35.0%±15.7
(p<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<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). Conclusion: Infants who were breast-fed and
an oral stimulation program proved beneficial in reducing transition time
from tube feeding to oral feeding. ClinicalTrials.gov number NCT03025815