Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm Infants
Primary Purpose
Body Weight Changes, Feeding and Eating Disorders of Childhood, Breast Feeding
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Adjusted individual feeding
Sponsored by
About this trial
This is an interventional prevention trial for Body Weight Changes focused on measuring preterm, oral feeding, outcome
Eligibility Criteria
Inclusion Criteria:
- birth at less than 32 weeks of gestation
Exclusion Criteria:
- High grade intraventricular hemorrhage (grade 3 or4)
- genetic syndrome
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
protocol feeding
Adjusted individual feeding
Arm Description
Feeding of preterm infants according to current unit protocol: every 3 hours a prescribed amount
Feeding every 2-4 hours, starting with que of hunger and finished upon infant signs.
Outcomes
Primary Outcome Measures
length of hospitalization
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
Secondary Outcome Measures
age at reaching full oral feedings
the age at which no nasogastric tube was used
Full Information
NCT ID
NCT01989871
First Posted
November 6, 2013
Last Updated
November 14, 2013
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01989871
Brief Title
Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm Infants
Official Title
Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 .
Detailed Description
Preterm infants born at <32 weeks of gestation at our institute will qualify for this study. Recruitment will occur between day 7-14 of life after sever brain malformations or intraventricular bleeding will be ruled out. Randomization to control or intervention will be via sealed envelopes. In the control group - infants will be treated according to the common practice in the neonatal intensive care unit. Transition to oral feeding will occur at 33 wkks (breast feeding) and 34 wks (bottle feeding). Meals will be given every 3 hours, the amount will be written by the care giving physician and will be written as a strict number (i.e 30 ml every 3 hours) Parents in the intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst them pace feeding. During the study parents in both groups will be interviewed every 14 days as for their satisfactions, anxieties, infants ability to cope. video typing during Kangaroo care at 32 and 35 wks as well as during feeding at 35 weeks will be done and evaluated. General movements assessment (neurodevelopment) will be done at 33 -35 weeks gestational age, as well as at 52 weeks. Alberta infant motor scales will be evaluated at 4 and 8 month corrected age,Automated Brain stem evoked Response (ABR) will be done at 33 wks for assessment of brain stem maturity, duration of hospitalization, weight gain per week at 33, 34 and 35 weeks will be calculated, age at full oral feeding will be noted. At the age of 6 month Griffith's developmental scales will be performed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes, Feeding and Eating Disorders of Childhood, Breast Feeding, Evoked Response Audiometry
Keywords
preterm, oral feeding, outcome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
protocol feeding
Arm Type
No Intervention
Arm Description
Feeding of preterm infants according to current unit protocol: every 3 hours a prescribed amount
Arm Title
Adjusted individual feeding
Arm Type
Experimental
Arm Description
Feeding every 2-4 hours, starting with que of hunger and finished upon infant signs.
Intervention Type
Behavioral
Intervention Name(s)
Adjusted individual feeding
Intervention Description
Feeding every 2-4 hours, starting with ques of hunger and finished upon infant signs.
Primary Outcome Measure Information:
Title
length of hospitalization
Description
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
Time Frame
between 36-40 weeks gestational age
Secondary Outcome Measure Information:
Title
age at reaching full oral feedings
Description
the age at which no nasogastric tube was used
Time Frame
between 34-38 gestational age
Other Pre-specified Outcome Measures:
Title
Griffith's developmental scales
Description
Griffith's developmental scales (Gross and fine motor, speech and language, performance and social skills)
Time Frame
6 month corrected age
Title
weekly weight gain
Description
weekly weight gain gr/kg will be calculated at 33 weeks gestational age, at 34, 35, and 36 weeks
Time Frame
33- 36 weeks gestational age
Title
parental anxiety
Description
parents anxiety will be assessed by a questioner
Time Frame
6 month corrected age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- birth at less than 32 weeks of gestation
Exclusion Criteria:
High grade intraventricular hemorrhage (grade 3 or4)
genetic syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Morag, MD
Phone
+526479996
Email
irismorag@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
tzipi Strauss, MD
Phone
+526664446
Email
t.tzipi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Morag, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Morag, MD
Phone
+526479996
Email
irismorag@gmail.com
First Name & Middle Initial & Last Name & Degree
Tzipi Strauss, MD
Phone
+526664446
First Name & Middle Initial & Last Name & Degree
Iris Morag, MD
12. IPD Sharing Statement
Learn more about this trial
Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm Infants
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