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

NCT ID: NCT02916914

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-08-01

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.

Conditions

Bottlefeeding; Infant, Premature, Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Q2 feeding

feeding intervals: 2 hours

Group Type: OTHER

Q2 feeding

Intervention Type: OTHER

Infants are going to be fed every 2 hours

Q3feeding

feeding intervals: 3 hours

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Q2 feeding

Infants are going to be fed every 2 hours

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 90 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

UNKNOWN

Sponsor Role: lead

Responsible Party

Sezin Unal

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sezin Unal, MD

Role: PRINCIPAL_INVESTIGATOR

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Locations

EtlikWHTH

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 23662739 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19330703 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18422805 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21252961 (View on PubMed)

Other Identifiers

EZH/2015/4

Identifier Type: -

Identifier Source: org_study_id