Infant, Premature, Diseases Clinical Trial
Official title:
Efficacy of a Manual Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition
Verified date | October 2018 |
Source | Fundacion Para La Investigacion Hospital La Fe |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | September 15, 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Weeks to 30 Weeks |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario y Politécnico La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Fundacion Para La Investigacion Hospital La Fe |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | An average of 20 days after the baby is 32 weeks (32+0 to 32+6) | |
Primary | 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 |
An average of 10 days after the baby is 32 weeks (32+0 to 32+6) | |
Primary | 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. |
An average of 25 days after the baby is 32 weeks (32+0 to 32+6) | |
Primary | 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. | An average of 9 weeks after the baby was hospitalized | |
Secondary | 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. |
When babies are discharged from the hospital, an average of 9 weeks after the babies were hospitalized |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05030337 -
Optimising Ventilation in Preterms With Closed-loop Oxygen Control
|
N/A | |
Completed |
NCT02916914 -
Impact of Feeding Interval of Preterms on the Time of Transition From Tube Feeding to Oral Feeding
|
N/A | |
Not yet recruiting |
NCT06335524 -
Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants
|
N/A | |
Completed |
NCT02391389 -
VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping
|
N/A | |
Completed |
NCT00419588 -
Growth of Airways and Lung Tissues in Premature and Healthy Infants
|
||
Completed |
NCT05217186 -
Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
|
||
Completed |
NCT04886310 -
Peabody Developmental Motor Scale-2 in 0 - 24 Months in Turkey
|
||
Enrolling by invitation |
NCT04478487 -
Novel Human Milk Based Human Milk Fortifier
|
N/A | |
Not yet recruiting |
NCT05592431 -
Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates
|
N/A | |
Enrolling by invitation |
NCT05011071 -
The Alberta BLOOM Premature Child Study
|
||
Completed |
NCT04889846 -
The Effects of SAFE Early Intervention Approach in Premature Infants in Turkey
|
N/A | |
Recruiting |
NCT04064398 -
Evaluation of Gastric Residuals and Feedings Progression
|
N/A | |
Completed |
NCT04500353 -
Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial
|
N/A | |
Completed |
NCT04247308 -
Multi Modal Stimulations in Pre-term Neonates
|
N/A | |
Completed |
NCT03860142 -
Evolution of Food Orality in Children Aged Between 24 and 36 Months: Comparison of the Severity and Specificities of Disorders Between Two Populations of Children, Born Very Prematurely and Born at Term
|
||
Completed |
NCT04234152 -
Complete Shielding of Multivitamins to Reduce Toxic Peroxides in the Parenteral Nutrition: A Pilot Study
|
N/A | |
Terminated |
NCT04641000 -
The Alberta BLOOM Long Term Follow Up Study
|
||
Completed |
NCT04284891 -
Critical Respiratory Diseases in Ex-preterm Infants in PICU
|
||
Completed |
NCT04327466 -
Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants
|
N/A | |
Completed |
NCT00062452 -
Esophageal Motility and Airway Defenses Among Infants
|
N/A |