Effects of Oral Stimulation in Preterm Infants

Eating Disorder Clinical Trial

Official title:

Effects of Oral Stimulation on Feeding Performance, Length of Hospital Stay and Anthropometric Variables of Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911674
• Other study ID #: CEU-0013
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: April 2019
• Source: CEU San Pablo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

Inclusion Criteria:

• Preterm infants with gestational age inferior to 34 weeks

Exclusion Criteria:

• Instability caused by respiratory, cardiac or gastrointestinal issues

• Orofacial malformations.

Related Conditions & MeSH terms

• Eating Disorder
• Feeding and Eating Disorders
• Premature Infant

Intervention

Other:
• Oral manual stimulation of feeding in preterm infants
Manual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin.

Locations

Country	Name	City	State
Spain	CEU San Pablo University	Madrid	Comunidad De Madrid

Sponsors (1)

Lead Sponsor	Collaborator
CEU San Pablo University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age at the initiation of oral feeding		Up to 46 weeks
Primary	Weight at discharge (g)		Up to 46 weeks
Primary	Height at discharge (cm)		Up to 46 weeks
Primary	Head circumference at discharge (cm)		Up to 46 weeks
Primary	Days of enteral nutrition		Up to 46 weeks
Primary	Gestational age at discharge (weeks)		Up to 46 weeks
Primary	Total length of hospitalization		Up to 46 weeks