Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01987154
Other study ID # 6020
Secondary ID
Status Completed
Phase N/A
First received November 5, 2013
Last updated May 16, 2016
Start date February 2014
Est. completion date March 2016

Study information

Verified date May 2016
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority Italian: Medicines Agency
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Infant's mother plans to exclusively breast feed

- 5 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)


Related Conditions & MeSH terms


Intervention

Other:
Marketed cow milk-based premature infant formula

Marketed extensively hydrolyzed casein infant formula


Locations

Country Name City State
Italy Azienda Ospedaliera "Ospedale Policlinico Consorziale" di Bari Bari Apulia

Sponsors (1)

Lead Sponsor Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Enteral intake (ml/kg/day) Daily for 14 days Yes
Secondary Body Weight (g) Daily for 14 days Yes
Secondary Feeding Tolerance Gastric residuals, regurgitation(>1 ml), fecal output (number of stools per day) Daily for 14 days No
Secondary Respiratory status Apnea and/or bradycardia events, use of supplemental oxygen, use of mechanical ventilation Daily for 14 days Yes
Secondary Gut Inflammation Fecal calprotectin, alpha and beta defensins, TNF alpha, gastric ultrasound Once at Study Day 14 No
Secondary Confirmed or suspected sepsis or necrotizing enterocolitis Daily for 14 days Yes
Secondary Date of hospital discharge Once at hospital discharge No
Secondary Growth length (cm) and head circumference (cm) Study Days 1, 7, and 14 Yes
See also
  Status Clinical Trial Phase
Terminated NCT03320785 - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Completed NCT00997854 - Preterm Neonatal Feeding Protocol Comparing Feed Administration Time N/A
Completed NCT02980250 - Multi-Center Study of Different Doses Domperidone in Feeding Intolerance Phase 4
Not yet recruiting NCT02534090 - Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy N/A
Recruiting NCT02149407 - Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants N/A
Completed NCT03822104 - Bovine Colostrum as a Human Milk Fortifier for Preterm Infants N/A
Recruiting NCT05347706 - Protocol for Feeding Intolerance in Preterm Infants N/A
Completed NCT00331201 - SAFEstart Feeding Intolerance Study Phase II Phase 2
Recruiting NCT02598375 - Evaluation of Status of Early Reached Target Enteral Nutrition and IFABP as Biomarker of Feeding Intolerance in Critically Ill Children N/A
Terminated NCT02028156 - Feeding Intolerance in Formula-Fed Infants N/A
Completed NCT01191112 - Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population Phase 3
Completed NCT01441427 - Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial Phase 1/Phase 2
Completed NCT02054091 - Feeding Bovine Colostrum to Preterm Infants N/A
Recruiting NCT00450697 - Feeding Tolerance in Preterm Infants N/A
Completed NCT03537365 - Bovine Colostrum as a Fortifier Added to Human Milk for Preterm Infants N/A
Completed NCT04304807 - Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants Phase 4
Not yet recruiting NCT00550069 - Observational Study of Infants Born at 34 to 37 Weeks of Gestation Until the Age of 1 Year N/A
Not yet recruiting NCT04950738 - The Effectiveness of Acupuncture for Complications in Critically Ill Patients N/A