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Completed

NCT Number: NCT02916914

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

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.

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Key information

Conditions

Bottlefeeding Behavior Bottle Feeding Congenital, Hereditary, and Neonatal Diseases and Abnormalities Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

7 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EtlikWHTH

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • birth weight <= 1500 gr gr
  • gestational age <= 32 weeks
  • postnatal age at randomization: between 7 - 90 days

Exclusion criteria

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

Treatment and study plan

Q2 feeding

Other

Infants are going to be fed every 2 hours

Primary outcomes

  1. time of transition from orogastric to oral feeding

    Time frame: 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

  1. feeding intolerance after randomization; intolerance events per week until discharge

    Time frame: 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

  2. duration of hospitalization

    Time frame: 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)

  3. weight gain per week until discharge

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Unknown

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2016
Registry last updated
Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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