Preterm Neonatal Feeding Protocol Comparing Feed Administration Time

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00997854

Enrollment

136

Registered

2009-10-19

Start date

2009-10-31

Completion date

2010-10-31

Last updated

2019-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Intolerance

Keywords

Feeding, Intolerance, Preterm, Bolus

Brief summary

Doctors have tried many different methods of feeding to try to decrease feeding intolerance in preterm babies so that they spend less time receiving liquid nutrition and have fewer problems with feeding intolerance. The purpose of this study is to test two different methods of feeding preterm babies in the hopes of identifying a method that will decrease some of the feeding intolerance that can occur when feeding premature babies.

Interventions

OTHERLength of time for feed administration

Group 1 will consist of babies fed by bolus method, administered over no more than 30 minutes. Group 2 will be fed by slow infusion by pump over 2 hours.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 32 Weeks

Healthy volunteers

Yes

Inclusion criteria

* Any infant born at OHSU or transferred in from another facility whose birthweight is greater than 500 grams and less than 1500 grams, and whose gestational age is less than 32 weeks.

Exclusion criteria

* Any infant who has major anomalies including but not limited to \*gastroschisis * omphalocele * bowel obstruction or atresia * tracheo-esophageal fistula * Hirschsprung's Disease * congenital diaphragmatic hernia * congenital heart disease and other major syndromes * infants who have started enteral feeds prior to entering the study * Any infant whose birth weight is greater than or equal to 1500 grams or less than 500 grams * Any infant whose gestational age is greater than 32 weeks.

Design outcomes

Primary

Measure	Time frame
To compare feeding intolerance between these two groups as defined by the following criteria: the number of times that the signs and symptoms in an infant caused the perception of feeding intolerance with feeds paused for longer than one feeding.	Daily

Secondary

Measure	Time frame
To compare the number of days it takes the infant to reach full feeds.	After reaching full feeds.
To compare the number of days the infant requires intravenous nutrition.	After reaching full feeds.
To compare the number of days of overall hospitalization duration.	After patient discharge.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026