Preterm Neonatal Feeding Protocol Comparing Feed Administration Time

NCT ID: NCT00997854

Last Updated: 2019-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Feeding Intolerance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1 Bolus Feeds

This group will receive feeds administered by bolus method over no more than 30 minutes per feed.

Group Type ACTIVE_COMPARATOR

Length of time for feed administration

Intervention Type OTHER

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.

Group 2- Slow Infusion Feeds

This group will receive feeds administered by slow infusion over pump for 2 hours.

Group Type EXPERIMENTAL

Length of time for feed administration

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Length 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sue Ann Smith

MD, Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sue Ann Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oregon Health & Sciences University

Portland, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5376

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exclusive Enteral Nutrition in Preterm Neonates
NCT04337710 ACTIVE_NOT_RECRUITING NA
Preterm Infant Growth
NCT01162798 COMPLETED NA