Effects of the Oral Stimulation Program in Extreme Preterm Infants

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Feeding Behavior; Infant, Premature

Treatments: Other: Intervention group; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03025815

41366915.5.0000.5327

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 26 to 32 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Intervention group

Experimental group

Description:

Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.

Treatment:

Other: Intervention group

Control group

Sham Comparator group

Description:

sham stimulation program consists of the same researcher placing her hands for 15 minutes.

Treatment:

Other: Control group