Clinical Trial: Efficacy of an Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of a Manual Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition

Brief Summary:

Oral feeding in the neonatal period requires an accurate coordination between suction, swallowing and breathing. In premature new-borns and, depending on their gestational age, the coordinated work of those processes becomes jeopardised, being necessary to begin with an artificial enteral feeding. This situation results in lengthen their stay at the hospital until they are able to respond in a reliable way to their nutritional requirements orally, maintaining an adequate daily weight gain and without endangering their cardiorespiratory system.

This project is an experimental, prospective, blinded, randomized study, aimed to determine whether the application of a manual oral stimulation protocol in premature infants, hospitalized in a neonatal unit, reduces the transition time from enteral feeding to oral full feeding, while improves quality of feeding and shortens hospitalization time.


Detailed Summary:
Sponsor: Fundacion Para La Investigacion Hospital La Fe

Current Primary Outcome:

  • T1: Time elapsed, in days, from the end of the oral stimulation protocol (OSP) until the baby is able to ingest, through nutritive suction,100% of the total of the corresponding intake for his/her weight. [ Time Frame: An average of 20 days after the baby is 32 weeks (32+0 to 32+6) ]
    A neonatology nurse, blinded to the study, routinely records, after each intake and on the habitual nursing evolution sheet, the amounts of milk that prematures take and the way of feeding (enteral, oral), among other factors (height, weight, percentile, incidences...). When the premature reaches 30 weeks of gestational age (30 + 0 to 30 + 6), the physiotherapist perform the ten-day manual oral stimulation protocol. The researchers will look at the nursing evolution sheet, the time (days) elapsed from the end of the protocol (equivalent day in control group) to the day in which babies are able to take 100% of the corresponding intake for their weight. Is estimated that experimental group will reach this goal approximately 3 days before than control group.
  • T2: Time elapsed, in days, from the end of the OSP until the baby is able to ingest, through nutritive suction, 30% of the total of the corresponding intake for his/her weight. [ Time Frame: An average of 10 days after the baby is 32 weeks (32+0 to 32+6) ]

    30% suction without complications means that the baby already has the reflexes integrated and is able to coordinate suction, swallowing and breathing.

    A neonatology nurse, blinded to the study, routinely records, after each intake and on the habitual nursing evolution sheet, the amounts of milk that prematures take and the way of feeding (enteral, oral

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Weight gain of babies [ Time Frame: When babies are discharged from the hospital, an average of 9 weeks after the babies were hospitalized ]

    Improving the weight gain of experimental group is also one of the main results in similar studies.

    When babies are discharged from the hospital, researchers look at the nursing evolution sheet, their weight gain (percentile) along their hospitalization.



    Original Secondary Outcome: Same as current

    Information By: Fundacion Para La Investigacion Hospital La Fe

    Dates:
    Date Received: December 30, 2016
    Date Started: July 2015
    Date Completion: February 2017
    Last Updated: January 7, 2017
    Last Verified: January 2017