Impact of Feeding Interval of Preterms on the Time of Transition From Tube Feeding to Oral Feeding
Primary Purpose
Bottlefeeding, Infant, Premature, Diseases
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Q2 feeding
Sponsored by
About this trial
This is an interventional supportive care trial for Bottlefeeding focused on measuring preterm, feeding, oral transition
Eligibility Criteria
Inclusion Criteria:
- birth weight <= 1500 gr gr
- gestational age <= 32 weeks
- postnatal age at randomization: between 7 - 90 days
Exclusion Criteria:
- congenital anomaly
- multi organ failure
- sepsis
- surgical pathology
- inherited metabolic diseases
- exclusively formula feeding
Sites / Locations
- EtlikWHTH
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Q2 feeding
Q3feeding
Arm Description
feeding intervals: 2 hours
feeding intervals: 3 hours
Outcomes
Primary Outcome Measures
time of transition from orogastric to oral feeding
Secondary Outcome Measures
feeding intolerance after randomization; intolerance events per week until discharge
duration of hospitalization
weight gain per week until discharge
Full Information
NCT ID
NCT02916914
First Posted
September 8, 2016
Last Updated
August 13, 2017
Sponsor
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02916914
Brief Title
Impact of Feeding Interval of Preterms on the Time of Transition From Tube Feeding to Oral Feeding
Official Title
Impact of Feeding Interval of Preterms on the Time of Transition From Tube Feeding to Oral Feeding
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 30, 2016 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Preterms are usually fed with intervals of either two or three hours during their stay in neonatal intensive care unit. Recommendations of World Health Organization about feeding regimens, 3-hourly for infants 1500 - 2000 gr, and 2-hourly for infants 1000 - 1500 gr, are not proposed with regards to results of randomized controlled trials. Investigators aimed to investigate the impact of 2-hourly feeding on time of transition from orogastric to oral feeding.
Detailed Description
Preterms are usually fed with intervals of either two or three hours during their stay in neonatal intensive care unit. Recommendations of World Health Organization about feeding regimens, 3-hourly for infants 1500 - 2000 gr, and 2-hourly for infants 1000 - 1500 gr, are not proposed with regards to results of randomized controlled trials.
Stomach volume of preterms varies a wide range of upto 20 ml. This should be taken into consideration during the process of feeding of preterms in neonatal intensive care unit. Trials were focused on early neonatal outcomes and it was found that duration of phototherapy and nasal noninvasive ventilation, and time to achieve full enteral feeds were shorter during 2-hourly feeding when compared to 3-hourly feeding, on the other hand 3-hourly feeding was shown to accelerate the stomach emptying. Besides, duration of catheterization, and ratio of feeding intolerance, apnea, and hypoglycemia were found to be similar infants who fed either 2 or 3-hourly.
Investigators aimed to investigate the impact of two feeding regimens, 2-hourly or 3-hourly, on time of transition from orogastric to oral feeding in preterms.
Patients and Methods: Preterms of birth weight less that 1500 gr and gestational age smaller than 32 weeks are going to be eligible for study if no congenital anomalies exist. Regarding current clinical protocol infants are fed every 2 hours until they weigh 1500 gr, and every 3 hours afterwards. At the day that the infants reach 1500 gr of body weight, a randomization will be performed in to two groups, Intervention group: Q2 interval (2-hourly feeding) or Control group: Q3 interval (3-hourly feeding), due to study protocol. Infants with inherited metabolic disorders, congenital anomalies, neonatal sepsis, and surgical diseases and the ones who fed with exclusively formula will be excluded.
After randomization infants will be followed until discharge. The type of feeding, volume of each feed, weight gain per week, feeding intolerance (abdominal distention, vomiting, apnea, newly onset or increase of oxygen treatment demand), day of first oral feeding, time of transition from orogastric tube to oral feeding, duration of hospitalization will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bottlefeeding, Infant, Premature, Diseases
Keywords
preterm, feeding, oral transition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Q2 feeding
Arm Type
Other
Arm Description
feeding intervals: 2 hours
Arm Title
Q3feeding
Arm Type
No Intervention
Arm Description
feeding intervals: 3 hours
Intervention Type
Other
Intervention Name(s)
Q2 feeding
Intervention Description
Infants are going to be fed every 2 hours
Primary Outcome Measure Information:
Title
time of transition from orogastric to oral feeding
Time Frame
From date of birth to date of transition from orogastric to oral feeding or date of death, which ever came first, will be assessed up to 44th post menstrual age (days of life)
Secondary Outcome Measure Information:
Title
feeding intolerance after randomization; intolerance events per week until discharge
Time Frame
From date of randomization to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age
Title
duration of hospitalization
Time Frame
From date of birth to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age, (days of life)
Title
weight gain per week until discharge
Time Frame
From date of randomization to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age, (grams/kg/week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
birth weight <= 1500 gr gr
gestational age <= 32 weeks
postnatal age at randomization: between 7 - 90 days
Exclusion Criteria:
congenital anomaly
multi organ failure
sepsis
surgical pathology
inherited metabolic diseases
exclusively formula feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sezin Unal, MD
Organizational Affiliation
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
EtlikWHTH
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23662739
Citation
Bergman NJ. Neonatal stomach volume and physiology suggest feeding at 1-h intervals. Acta Paediatr. 2013 Aug;102(8):773-7. doi: 10.1111/apa.12291. Epub 2013 Jun 3.
Results Reference
background
PubMed Identifier
19330703
Citation
Dhingra A, Agrawal SK, Kumar P, Narang A. A randomised controlled trial of two feeding schedules in neonates weighing <or=1750 g. J Matern Fetal Neonatal Med. 2009 Mar;22(3):198-203. doi: 10.1080/14767050802385749.
Results Reference
background
PubMed Identifier
18422805
Citation
Rudiger M, Herrmann S, Schmalisch G, Wauer RR, Hammer H, Tschirch E. Comparison of 2-h versus 3-h enteral feeding in extremely low birth weight infants, commencing after birth. Acta Paediatr. 2008 Jun;97(6):764-9. doi: 10.1111/j.1651-2227.2008.00774.x. Epub 2008 Apr 16.
Results Reference
background
PubMed Identifier
21252961
Citation
DeMauro SB, Abbasi S, Lorch S. The impact of feeding interval on feeding outcomes in very low birth-weight infants. J Perinatol. 2011 Jul;31(7):481-6. doi: 10.1038/jp.2010.153. Epub 2011 Jan 20.
Results Reference
background
Learn more about this trial
Impact of Feeding Interval of Preterms on the Time of Transition From Tube Feeding to Oral Feeding
We'll reach out to this number within 24 hrs