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Effects of Oral Stimulation in Preterm Infants

C

CEU San Pablo University

Status and phase

Completed
Phase 3

Conditions

Eating Disorder
Premature Infant

Treatments

Other: Oral manual stimulation of feeding in preterm infants

Study type

Interventional

Funder types

Other

Identifiers

NCT03911674
CEU-0013

Details and patient eligibility

About

Preterm infants with gestational age inferior to 34 weeks were included in the study. A prospective experimental group received the oral stimulation protocol and the effects of the intervention were compared with a historical control group that did not receive any oral stimulation intervention.

The study hypothesis is that oral stimulation in preterm infants has beneficial effects on the feeding performance, the length of hospitalization and anthropometric variables, including weight at discharge, height at discharge and head circumference at discharge.

Enrollment

48 patients

Sex

All

Ages

Under 7 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Preterm infants with gestational age inferior to 34 weeks

Exclusion criteria

  • Instability caused by respiratory, cardiac or gastrointestinal issues
  • Orofacial malformations.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

Oral stimulation
Experimental group
Description:
Oral stimulation protocol: manual stimulation of the oral sucking
Treatment:
Other: Oral manual stimulation of feeding in preterm infants
Control
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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