- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01989871
Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm Infants
Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm
The authors hypothesize that adjusted individual feeding (AIF) for preterm infant starting from transition to oral feeding (33 weeks corrected age) will result in less episodes of apnea/bradycardia, early achievement of full oral feeding, improved weight gain and shorten hospitalization duration in the short term.
In the long term AIF will result in higher scores on the Griffith's developmental scales, decreasing parental anxiety and feeding disorders .
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Iris Morag, MD
- Phone Number: +526479996
- Email: irismorag@gmail.com
Study Contact Backup
- Name: tzipi Strauss, MD
- Phone Number: +526664446
- Email: t.tzipi@gmail.com
Study Locations
-
-
-
Ramat Gan, Israel, 52621
- Sheba Medical Center
-
Contact:
- Iris Morag, MD
- Phone Number: +526479996
- Email: irismorag@gmail.com
-
Contact:
- Tzipi Strauss, MD
- Phone Number: +526664446
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- birth at less than 32 weeks of gestation
Exclusion Criteria:
- High grade intraventricular hemorrhage (grade 3 or4)
- genetic syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: protocol feeding
Feeding of preterm infants according to current unit protocol: every 3 hours a prescribed amount
|
|
Experimental: Adjusted individual feeding
Feeding every 2-4 hours, starting with que of hunger and finished upon infant signs.
|
Feeding every 2-4 hours, starting with ques of hunger and finished upon infant signs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
length of hospitalization
Time Frame: between 36-40 weeks gestational age
|
length of hospitalization from admission to discharge, and length of stay beyond reaching 36 weeks corrected age , the time point at wich health infants are usually being discharged
|
between 36-40 weeks gestational age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
age at reaching full oral feedings
Time Frame: between 34-38 gestational age
|
the age at which no nasogastric tube was used
|
between 34-38 gestational age
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Griffith's developmental scales
Time Frame: 6 month corrected age
|
Griffith's developmental scales (Gross and fine motor, speech and language, performance and social skills)
|
6 month corrected age
|
weekly weight gain
Time Frame: 33- 36 weeks gestational age
|
weekly weight gain gr/kg will be calculated at 33 weeks gestational age, at 34, 35, and 36 weeks
|
33- 36 weeks gestational age
|
parental anxiety
Time Frame: 6 month corrected age
|
parents anxiety will be assessed by a questioner
|
6 month corrected age
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Iris Morag, MD, Sheba Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-12-9574-IM-CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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