Clinical trial NCT03025815: Effects of the Oral Stimulation Program in Extreme Preterm Infants
Official title: Effects of the Oral Stimulation Program in Extreme Preterm Infants: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Feeding Behavior
Keywords: Infant, Premature
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 74
Sex: ALL
Minimum age (years): 26
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether oral stimulation program are effective to improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized classification of the subjects into to experimental and a control group.

Detailed description: Recent studies have suggested that an oral stimulation program applied to preterm infants facilitates their oral feeding progress, improve breastfeeding rates in preterm infants and decreases the length of hospital stay. The objective of this study will evaluate the effect an oral stimulation program on the performance feeding, the length of the transition oral feeding, length of hospital stay and breastfeeding rates upon discharge.

Primarily, will be evaluated the effect an oral stimulation program on the performance feeding. All infants will be assessed by a speech pathologist blinded as to the group randomization.

Secondarily, will be observed the length of the transition oral feeding of the preterm infants, conducted by medical team and will be observed length of hospital stay. Both groups will be monitored from when they were assigned to participate in the study until hospital discharge.

All statistical will be conducted using Statistical Package for Social Sciences® version 18.0. The data will be analyzed for treatment group differences with chi-square or Fisher's exact tests for the categorical variables and with non-parametric tests for the continuous variables.

Eligibility criteria: Inclusion Criteria:

* infants with between 26 and 32 weeks gestational age as determined by date of last menstruation and first trimester ultrasound or by clinical examination.

Exclusion Criteria:

* infants with medical complications, such as grades III or IV intraventricular hemorrhage or periventricular leukomalacia
* congenital diseases such as chromosomal or genetic abnormalities
* bronchopulmonary dysplasia
* necrotizing enterocolitis.

Primary outcomes:
measure: Oral feeding performance
timeFrame: 20 minutes
Secondary outcomes:
measure: Oral feeding transition time
timeFrame: 60 days
measure: Days hospital stay
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Neonatal Section
name: Rita C Silveira, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: da Rosa Pereira K, Levy DS, Procianoy RS, Silveira RC. Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial. PLoS One. 2020 Sep 9;15(9):e0237915. doi: 10.1371/journal.pone.0237915. eCollection 2020.