NCT01987154

Brief Summary

To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2.1 years

First QC Date

November 5, 2013

Last Update Submit

May 16, 2016

Conditions

Feeding Intolerance

Outcome Measures

Primary Outcomes (1)

  • Enteral intake (ml/kg/day)

    Daily for 14 days

Secondary Outcomes (7)

  • Body Weight (g)

    Daily for 14 days

  • Feeding Tolerance

    Daily for 14 days

  • Respiratory status

    Daily for 14 days

  • Gut Inflammation

    Once at Study Day 14

  • Confirmed or suspected sepsis or necrotizing enterocolitis

    Daily for 14 days

  • +2 more secondary outcomes

Study Arms (2)

Marketed cow milk-based premature infant formula

ACTIVE COMPARATOR
Other: Marketed cow milk-based premature infant formula

Marketed extensively hydrolyzed casein infant formula

EXPERIMENTAL
Other: Marketed extensively hydrolyzed casein infant formula

Interventions

Marketed cow milk-based premature infant formulaOTHER
Marketed cow milk-based premature infant formula
Marketed extensively hydrolyzed casein infant formulaOTHER
Marketed extensively hydrolyzed casein infant formula

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Premature infant 28 to 33 weeks gestational age, inclusive, at birth
  • Infant has never received enteral feedings or current enteral intake is less than 30 mL/kg/day
  • Birth weight is greater than or equal to 700g to 1750g
  • Appropriate birth weight for gestational age
  • Singleton or twin birth
  • Signed Informed consent

You may not qualify if:

  • Infant's mother plans to exclusively breast feed
  • minute APGAR score is less than or equal to 4
  • Major surgery that required general anesthesia prior to randomization
  • Ventilator-dependent or requiring greater than 40% FiO2 on day of randomization
  • Grade III or IV intraventricular hemorrhage diagnosed prior to randomization
  • Infant is currently participating in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera "Ospedale Policlinico Consorziale" di Bari

Bari, Apulia, 70124, Italy

Location

Study Officials

  • Mariella Baldassarre, M.D.

    Universita degli Studi di Bari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 19, 2013

Study Start

February 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

IT(1)