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Completed

NCT Number: NCT03911674

Effects of Oral Stimulation in Preterm Infants

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.

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Key information

Conditions

Premature Infant Eating Disorder Feeding and Eating Disorders Female Urogenital Diseases and Pregnancy Complications Mental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEU San Pablo University

Madrid, 28668, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infants with gestational age inferior to 34 weeks

Exclusion criteria

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

Treatment and study plan

Oral manual stimulation of feeding in preterm infants

Other

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

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

Sponsors and collaborators

Lead sponsor

CEU San Pablo University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2019
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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