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

E

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Status

Completed

Conditions

Infant, Premature, Diseases
Bottlefeeding

Treatments

Other: Q2 feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT02916914
EZH/2015/4

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

7 to 90 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. birth weight <= 1500 gr gr
  2. gestational age <= 32 weeks
  3. postnatal age at randomization: between 7 - 90 days

Exclusion criteria

  • congenital anomaly
  • multi organ failure
  • sepsis
  • surgical pathology
  • inherited metabolic diseases
  • exclusively formula feeding

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Q2 feeding
Other group
Description:
feeding intervals: 2 hours
Treatment:
Other: Q2 feeding
Q3feeding
No Intervention group
Description:
feeding intervals: 3 hours

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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