NCT03214744

Brief Summary

Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

July 9, 2017

Last Update Submit

July 12, 2017

Conditions

Preterm Infant

Outcome Measures

Primary Outcomes (1)

  • effect of entral feeding on preterm

    -Length of hospital stay.

    six months

Eligibility Criteria

Age1 Week - 15 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Neonates (\<36 weeks)

You may qualify if:

  • \- All preterm neonates admitted to NICU with gestational age less than 36 weeks, and haemodynamically stable

You may not qualify if:

  • gastrointestinal tract anomalies,
  • haemodynamically unstable infants,
  • gestatinal age equal or more than 36 weeks,
  • preterms who develop NEC,
  • preterms on mechanical ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

Location

Related Publications (1)

  • Pike K, Brocklehurst P, Jones D, Kenyon S, Salt A, Taylor D, Marlow N. Outcomes at 7 years for babies who developed neonatal necrotising enterocolitis: the ORACLE Children Study. Arch Dis Child Fetal Neonatal Ed. 2012 Sep;97(5):F318-22. doi: 10.1136/fetalneonatal-2011-300244.

    PMID: 22933088BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • John J Smith

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

professor Mohamed Mahrous Sayed

CONTACT

01003486595Eltellawy270@hotmail.com

Lecture Safwat Mohammed Abdel-Aziz

CONTACT

01003918080Safwatabdaziz371@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants

Study Record Dates

First Submitted

July 9, 2017

First Posted

July 12, 2017

Study Start

May 1, 2018

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

July 17, 2017

Record last verified: 2017-07

Locations

EG(1)