Survey of Different Modes of Weaning in Pediatric Population

NCT06839846 | Recruiting

• 1 other identifier: DIVPED
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

Brief Summary

Infant weaning refers to the transition from a diet based on the exclusive intake of milk (mother's milk or formula) to a diversified diet that is complete with all the nutrients necessary for proper infant development. For this purpose, a diet supplementary to milk, which is gradually reduced, is undertaken in order to gradually acquire the dietary pattern followed by the family. There are different types of weaning, which vary according to traditions, ethnicity and scientific currents. These include traditional weaning and on-demand self-weaning. The former consists of weaning with specific infant foods (example: freeze-dried, homogenized, vegetable broth, creams..) offered at set doses, quantities, and times. On the other hand, 'autodivezzamento on demand is a mode of weaning entrusted to the child's request, leaving the child to choose quantities and types of food, even prepared at home, during family meals. The aim of our study is to establish the prevalence of different modes of weaning and the perception of advantages and disadvantages related to them by parents and Free Choice Pediatricians by means of two different dedicated questionnaires. The study also aims to assess possible risks resulting from the transition to complementary feeding, for example, errors in feeding or inhalation of foreign bodies.

Conditions

Weaning

Keywords

weaning

Outcome Measures

Primary Outcomes (1)

• Evaluate how parents and pediatricians implement weaning

  * Percentage of parents choosing a particular weaning mode; * reasons expressed by Pediatricians of Free Choice in suggesting their chosen weaning mode.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Different ways of weaning suggestionated by free choice Pediatricians

  through study completion, an average of 1 year

Study Arms (2)

Parents

the survey will be proposed to adult parents of children aged 4-18 months by means of a specific questionnaire dedicated to them.

Pediatrician

another specific questionnaire intended for the Pediatrician will be proposed to PLSs who give their willingness.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participation will be offered to all parents who reflect the inclusion criteria by specifying the observational nature of the study and the importance of deepening the prevalence and knowledge of the different diveating modes. It is specified that one of the two parents will be sufficient to complete the questionnaire. In the case of twins, the questionnaire will include completion of the weaning questions for each child. These persons will be recruited from the wards and waiting rooms of the Centers participating in the study without retaining any personal data of the enrolled subject. Access to the online questionnaire will be via access link that will be provided to the subjects via e-mail to the address they provide.

You may qualify if:

• Parents group:
• Overage parents with children between the ages of 4 and 18 months
• Need to have an electronic tool that allows direct access to the link connected to an internet network
• Understanding of the Italian language
• Obtaining informed consent from the parent completing the questionnaire
• Pediatricians group:
• Activities of Free Choice Pediatrician in Italy.
• Need to have an electronic tool that allows direct access to the link connected to an Internet network
• Obtaining informed consent

You may not qualify if:

• Parents group:
• \- Parents of children with chronic neurological diseases, dysphagia, chronic diseases involving specific diet, intestinal diseases resulting in malabsorption;
• Pediatricians group:
• \- None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (4)

Ospedale S. Maria della Scaletta, Azienda USL di Imola UO Pediatria

Imola, Bologna, 40026, Italy

RECRUITING

Ospedale Ramazzini di Carpi, Azienda USL di Modena UO Pediatria

Carpi, Modena, 41012, Italy

RECRUITING

Ospedale Maggiore, Azienda USL di Bologna UO Pediatria

Bologna, 40133, Italy

RECRUITING

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva

Bologna, 40138, Italy

RECRUITING

Study Officials

• Arianna Dondi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arianna Dondi, MD

CONTACT

0512143012; arianna.dondi@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: February 21, 2025
• Study Start: April 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 21, 2025

Record last verified: 2024-10

Locations

IT (4)