Rapid Versus Slow Entral Feeding Advancements on Clinical... | NCT03214744

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

NCT03214744

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 17, 2017Actual

Enrollment

1Estimated

Phase

Not provided

Conditions

Preterm Infant

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2018Estimated

Primary Completion Date

Dec 2018Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Jul 9, 2017

First Submission Date that Met QC Criteria

Jul 9, 2017

First Posted Date

Jul 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2017

Last Update Posted Date

Jul 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amany Makrm Riad, Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Rapid feeding advancement achieves full enteral volume of feedings earlier than the slower advancement.They received significantly fewer days of parenteral nutrition, exhibited a shorter time to regain birth weight and shorter duration of hospital stay. The incidence of NEC and the number of episodes of feeding intolerance were not significantly different between rapid and slow advancement. while the incidence of culture-proven late onset sepsis was significantly less in infants receiving a rapid feeding advancement

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
effect of entral feeding on preterm	-Length of hospital stay.	six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Week

Maximum Age

15 Weeks

Standard Ages

Child

Study Population

Neonates (<36 weeks)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
professor Mohamed Mahrous Sayed	Contact	01003486595		Eltellawy270@hotmail.com
Lecture Safwat Mohammed Abdel-Aziz	Contact	01003918080		Safwatabdaziz371@yahoo.com

Overall Officials

Name	Affiliation	Role
John J Smith	National Institutes of Health Clinical Center (CC)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university		Asyut		71515	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22933088	Background	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.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications