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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03911674
Other study ID # CEU-0013
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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