Study in Unsettled Infants Experiencing Feeding Intolerance

• ClinicalTrials.gov Identifier: NCT02021058
• Recruitment Status: Completed
• First Posted: December 27, 2013
• Last Update Posted: January 31, 2017
• Sponsor: Nestlé
• Information provided by (Responsible Party): Nestlé

Tracking Information

• First Submitted Date: November 22, 2013
• First Posted Date: December 27, 2013
• Last Update Posted Date: January 31, 2017
• Actual Study Start Date: December 12, 2013
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 19, 2013)

Changes from baseline to 14 days in fuss-cry behavior [ Time Frame: from baseline to 14 days ]

fuss-cry behavior per 24 hours

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 19, 2013): Change from baseline to 14 days in GI symptoms [ Time Frame: from baseline to 14 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study in Unsettled Infants Experiencing Feeding Intolerance
• Official Title: Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance
• Brief Summary: Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance
• Detailed Description: The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Feeding Disorder

Intervention

• Other: Experimental Formula
  Experimental formula
• Other: Standard control formula
  Standard Infant formula

Study Arms

• Experimental: Experimental Formula
  Experimental Formula
  Intervention: Other: Experimental Formula
• Standard Formula
  Standard Control formula
  Intervention: Other: Standard control formula

• Publications *: Vivatvakin B, Estorninos E, Lien R, Lee HC, Hon KLE, Lebumfacil J, Cercamondi CI, Volger S. Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial. Glob Pediatr Health. 2020 Sep 25;7:2333794X20954332. doi: 10.1177/2333794X20954332. eCollection 2020.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 7, 2016): 259
• Original Estimated Enrollment (submitted: December 19, 2013): 260
• Actual Study Completion Date: August 23, 2016
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Full term infants, singleton, healthy at birth
2. Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
3. Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
4. Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.

Exclusion Criteria:

1. Infants who are consuming any amount of supplemental human milk
2. Infants who are consuming weaning foods or beverages other than infant formula
3. Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
4. Infants who have a medical condition or history that could cause or contribute to feeding intolerance
5. Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 90 Days (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hong Kong, Philippines, Taiwan, Thailand

Administrative Information

• NCT Number: NCT02021058
• Other Study ID Numbers: 13.10.INF
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Nestlé
• Study Sponsor: Nestlé
• Collaborators: Not Provided

Investigators

• Principal Investigator: Associate Professor Boosba Vivatvakin, MD; Pediatric Department, Faculty of Medicine, Chulalongkorn University

• PRS Account: Nestlé
• Verification Date: January 2017