Clinical trial NCT02916914: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bottlefeeding
Infant, Premature, Diseases
Keywords: preterm
feeding
oral transition
Lead sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: time of transition from orogastric to oral feeding
timeFrame: 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 outcomes:
measure: feeding intolerance after randomization; intolerance events per week until discharge
timeFrame: 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
measure: duration of hospitalization
timeFrame: 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)
measure: weight gain per week until discharge
timeFrame: 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)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: EtlikWHTH
Study officials:
affiliation: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
name: Sezin Unal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.