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Completed

NCT Number: NCT03016767

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

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.

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Key information

Conditions

Infant, Premature, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

25 week–30 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Babies between 25 + 0 to 30 + 6 weeks of gestation according to the last menstruation, with adequate weight and size for their gestational age, who are receiving orogastric tube feeding, presenting clinical hemodynamic and cardiorespiratory stability and without any associated pathology.

Exclusion criteria

  • Babies with congenital anomalies that affect feeding (chromosomopathies, craniofacial anomalies, severe esophageal or tracheal atresia, or any other that affect feeding),
  • Babies with abnormalities that alter digestive function such as "necrotizing enterocolitis".
  • Babies with other abnormalities that alter hemodynamic or cardiorespiratory stability, that present severe sepsis or positive meningitis culture, that suffer from chronic medical complications such as severe bronchopulmonary dysplasia, grade III or IV intraparaventricular hemorrhage, periventricular leukomalacia, etc.,
  • Inability to to assign an exact gestational age.

Treatment and study plan

Manual oral stimulation protocol

Procedure

Primary outcomes

  1. 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.

  2. 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), 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 30% of the corresponding intake for their weight. Is estimated that experimental group will reach this goal approximately 4-5 days before than control group

  3. T3: Time elapsed, in days, from the end of the OSP protocol until the baby is able to perform a full oral feeding, defined as the intake, by nutritive suction, of a quantity of milk ≥ 150 ml / kg / day , for three consecutive days.

    Time frame: An average of 25 days after the baby is 32 weeks (32+0 to 32+6)

    To be able to intake, by nutritive suction, of a quantity of milk ≥ 150 ml / kg / day , for three consecutive days (full oral feeding), is a discharge criterion in the Hospital la Fe of Valencia.

    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 a quantity of milk ≥ 150 ml / kg / day , for three consecutive days. Is estimated that experimental group will reach this goal approximately 4 days before than control group.

  4. T4: Time of hospitalization of the babies.

    Time frame: An average of 9 weeks after the baby was hospitalized

    When babies are discharged from the hospital, researchers calculate the difference between gestational age (GE) the day they are discharged and the GE they were hospitalized. Is estimated that experimental group will reach this goal approximately 3 days before than control group.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fundacion Para La Investigacion Hospital La Fe

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2017
Registry last updated
Oct 29, 2018

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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