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CompletedNCT03911674Updated Apr 11, 2019

Effects of Oral Stimulation in Preterm Infants

A Phase 3 interventional study of Oral manual stimulation of feeding in preterm infants in Premature Infant and Eating Disorder, sponsored by CEU San Pablo University. Completed at 1 site in Spain. Open to participants aged Up to 7 Days. Per ClinicalTrials.gov, last updated 2019-04-11.

Sponsored by CEU San Pablo University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Sep 2017, registered Mar 2019).
Phase
Phase 3
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
Up to 7 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Premature Infant
  • Eating Disorder
03

In context

Feeding and Eating Disorders

740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.

This study's enrollment of 48 is below the median of 75 across 540 interventional studies indexed under Feeding and Eating Disorders.

Browse Feeding and Eating Disorders studies →

Lead sponsor

CEU San Pablo University is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 7 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Preterm infants with gestational age inferior to 34 weeks

Exclusion criteria

Exclusion Criteria:

  • Instability caused by respiratory, cardiac or gastrointestinal issues
  • Orofacial malformations.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Oral stimulation

    Oral stimulation protocol: manual stimulation of the oral sucking

    Other: Oral manual stimulation of feeding in preterm infants

  • No intervention
    Control

    No intervention

Interventions

  • OtherOral manual stimulation of feeding in preterm infants

    Manual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin.

06

What researchers measure

Primary outcomes

  1. Gestational age at the initiation of oral feeding

    Time frame: Up to 46 weeks

  2. Weight at discharge (g)

    Time frame: Up to 46 weeks

  3. Height at discharge (cm)

    Time frame: Up to 46 weeks

  4. Head circumference at discharge (cm)

    Time frame: Up to 46 weeks

  5. Days of enteral nutrition

    Time frame: Up to 46 weeks

  6. Gestational age at discharge (weeks)

    Time frame: Up to 46 weeks

  7. Total length of hospitalization

    Time frame: Up to 46 weeks

07

Study locations

1 site
  • CEU San Pablo University
    Madrid, Comunidad De Madrid 28668, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03911674
Lead sponsor
CEU San Pablo University
Responsible party
Sponsor
First posted
Apr 11, 2019
Start date
Sep 1, 2017
Primary completion
Apr 1, 2018
Completion
Apr 1, 2018
Last update
Apr 11, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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