Back to resultsEfficacy of an Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition
Primary Purpose
Infant, Premature, Diseases
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual oral stimulation protocol
Sponsored by
About this trial
This is an interventional treatment trial for Infant, Premature, Diseases focused on measuring oral feeding, oral stimulation, physiotherapy intervention
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario y Politécnico La Fe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
oral stimulation
non oral stimulation
Arm Description
All the subjects of the study will receive the usual medical and nursing care for premature babies. They also will receive the physiotherapeutic treatment prescribed by the rehabilitation physician, focused mainly on respiratory and musculoskeletal care. Infants of the experimental group, in addition, will be applied a manual oral stimulation protocol designed ad hoc for this study, which consists of 12 maneuvers performed by a physiotherapist.
All the subjects of the study will receive the usual medical and nursing care for premature babies. They also will receive the physiotherapeutic treatment prescribed by the rehabilitation physician, focused mainly on respiratory and musculoskeletal care. But this group will not be applied the oral stimulation protocol.
Outcomes
Primary Outcome Measures
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.
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.
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
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.
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.
T4: Time of hospitalization of the babies.
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 Outcome Measures
Weight gain of babies
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.
Full Information
NCT ID
NCT03016767
First Posted
December 30, 2016
Last Updated
October 26, 2018
Sponsor
Fundacion Para La Investigacion Hospital La Fe
1. Study Identification
Unique Protocol Identification Number
NCT03016767
Brief Title
Efficacy of an Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition
Official Title
Efficacy of a Manual Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Para La Investigacion Hospital La Fe
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases
Keywords
oral feeding, oral stimulation, physiotherapy intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral stimulation
Arm Type
Experimental
Arm Description
All the subjects of the study will receive the usual medical and nursing care for premature babies. They also will receive the physiotherapeutic treatment prescribed by the rehabilitation physician, focused mainly on respiratory and musculoskeletal care.
Infants of the experimental group, in addition, will be applied a manual oral stimulation protocol designed ad hoc for this study, which consists of 12 maneuvers performed by a physiotherapist.
Arm Title
non oral stimulation
Arm Type
No Intervention
Arm Description
All the subjects of the study will receive the usual medical and nursing care for premature babies. They also will receive the physiotherapeutic treatment prescribed by the rehabilitation physician, focused mainly on respiratory and musculoskeletal care. But this group will not be applied the oral stimulation protocol.
Intervention Type
Procedure
Intervention Name(s)
Manual oral stimulation protocol
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
An average of 20 days after the baby is 32 weeks (32+0 to 32+6)
Title
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.
Description
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
Time Frame
An average of 10 days after the baby is 32 weeks (32+0 to 32+6)
Title
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.
Description
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.
Time Frame
An average of 25 days after the baby is 32 weeks (32+0 to 32+6)
Title
T4: Time of hospitalization of the babies.
Description
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.
Time Frame
An average of 9 weeks after the baby was hospitalized
Secondary Outcome Measure Information:
Title
Weight gain of babies
Description
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.
Time Frame
When babies are discharged from the hospital, an average of 9 weeks after the babies were hospitalized
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Weeks
Maximum Age & Unit of Time
30 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy of an Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition
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