Clinical Trials Directory

Trials / Completed

CompletedNCT02916914

Impact of Feeding Interval of Preterms on the Time of Transition From Tube Feeding to Oral Feeding

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital · Unknown
Sex
All
Age
7 Days – 90 Days
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERQ2 feedingInfants are going to be fed every 2 hours

Timeline

Start date
2016-09-30
Primary completion
2017-05-31
Completion
2017-08-01
First posted
2016-09-28
Last updated
2017-08-16

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT02916914. Inclusion in this directory is not an endorsement.