NCT00715000

Brief Summary

This prospective randomised study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 32 weeks GA (gestational age) aims to determine whether administration of a hypo-osmolar oral hydration solution is as efficient as intravenous infusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 25, 2013

Status Verified

April 1, 2013

Enrollment Period

2.1 years

First QC Date

July 11, 2008

Last Update Submit

April 24, 2013

Conditions

Low Birth Weight InfantEnteral Nutrition

Keywords

Preterm babies hydrationOral rehydration solutionContinuous gastric dripFluid therapyPremature babies comfortInfant careTechnical challenge for the nurses/doctors in charge

Outcome Measures

Primary Outcomes (1)

  • Weight

    Day 0 to day 16 or day of recovering original birth day

Secondary Outcomes (10)

  • Weight, length, head circumference and brachial circumference

    day 3, 15 of life, and at 37 GA.

  • Weight, Height/length, head circumference and brachial circumference

    6 and 12 months

  • pathologic digestive diseases (enteropathy, NEC…)

    J0 to J16

  • metabolic tolerance during the first week of life: - hypoglycemia - fructose intolerance - bilirubin, electrolytes and creatinin level in blood

    during the first week of life

  • pain and discomfort score (EDIN) evaluated 3 times a day

    Day 0 to day 16

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

SRO

Procedure: Oral rehydration therapy

2

ACTIVE COMPARATOR

classical hydration via intravenous infusion

Procedure: classical hydration via intravenous infusion

Interventions

Oral rehydration therapyPROCEDURE

oral rehydration solution

Also known as: SRO
1
classical hydration via intravenous infusionPROCEDURE

intravenous infusion

Also known as: IV
2

Eligibility Criteria

Age32 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants must be included within the first 12 to 24 hours of life
  • Good tolerance to nasogastric milk feeding
  • Necessity of additional fluid supply
  • Any suspicion of gastro intestinal or metabolic disease
  • Maximal humidity in incubator
  • Parental consent form

You may not qualify if:

  • suspicion of gastro-intestinal disease,
  • severe digestive risks, and metabolic diseases in the family history,
  • metabolic or hydro-electrolyte disorders
  • other severe diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Clamart, 92141, France

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Hasini RAZAFIMAHEFA, MD

    Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 14, 2008

Study Start

July 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2011

Last Updated

April 25, 2013

Record last verified: 2013-04

Locations

FR(1)