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

Infant, Premature, Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916914
• Other study ID #: EZH/2015/4
• Status: Completed
• Phase: N/A
• First received: September 8, 2016
• Last updated: August 13, 2017
• Start date: September 30, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2017
• Source: Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 1, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Days

Eligibility

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

Related Conditions & MeSH terms

• Bottlefeeding
• Infant, Premature, Diseases

Intervention

Other:
• Q2 feeding
Infants are going to be fed every 2 hours

Locations

Country	Name	City	State
Turkey	EtlikWHTH	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. Review. — View 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. — View 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. — View Citation

Rüdiger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of transition from orogastric to oral feeding		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	feeding intolerance after randomization; intolerance events per week until discharge		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
Secondary	duration of hospitalization		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)
Secondary	weight gain per week until discharge		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)