Study Protocol
Effect of Fortified Complementary Food on Iron Stores and Growth in Infants with Cleft Lip Palate–A Study Protocol for Randomized Control Trial
Kashamma V Uppin1*, Rajesh S Powar2 and Roopa M Bellad3
1Department of Public Health, Lecturer- Nutrition, JNMC, KAHER, Belagavi, Karnataka, India
2Department of Plastic and Reconstructive Surgery, HOD, Professor, JNMC, KAHER, Belagavi, Karnataka,India
3Department of Paediatrics, Professor, JNMC, KAHER, Belagavi, Karnataka, India
2Department of Plastic and Reconstructive Surgery, HOD, Professor, JNMC, KAHER, Belagavi, Karnataka,India
3Department of Paediatrics, Professor, JNMC, KAHER, Belagavi, Karnataka, India
*Corresponding author:Kashamma V Uppin, Department of Public Health, JNMC, KAHER, Belagavi, Karnataka, India, E-mail Id: uppinkashamma@gmail.com
Article Information: Submission: 07/03/2024; Accepted: 29/03/2024; Published: 06/04/2024
Copyright:© 2024 Uppin KV, et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Aim:To assess the effect of fortified complementary food in Infants with Cleft Lip Palate on Iron Stores, Growth and Neurodevelopment at 12 months.
Design:We devised a study protocol for a randomised controlled trial, which will be conducted between Nov 2022 and Nov 2024 in tertiary care hospital with study population of 130 infants with cleft aged 6 months. Eligible infants with cleft attending outpatient department will be recruited into the trial after obtaining consent.
Participants:One hundred and thirty-five eligible participants will be randomly assigned to a control group, receiving unfortified complementary food and to an experimental group receiving fortified complementary food for the duration of 6 months. Primary outcome of the study is to see improvement in body iron store as measured by Hemoglobin, S Ferritin, S Iron, TIBC and S Zinc and Secondary Outcome is improvement in growth in terms of weight, length and head circumference and Neurodevelopment Assessment using the Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III)
Expected Outcome:To achieve optimal growth in infants with cleft lip and palate and be ready for timely surgery, it is critical to implement appropriate nutrition interventions and nutrition education to the family. It’s a study protocol and expecting a change in body iron stores by 20% and improvement in growth and neurodevelopment of the infant with cleft.
Ethics and Dissemination:This study is approved by Institute’s Ethics Committees. The results will be disseminated through peer-reviewed publications and presentations targeting the global and local research communities. Trial registration number: CTRI/2022/11/047579.
Design:We devised a study protocol for a randomised controlled trial, which will be conducted between Nov 2022 and Nov 2024 in tertiary care hospital with study population of 130 infants with cleft aged 6 months. Eligible infants with cleft attending outpatient department will be recruited into the trial after obtaining consent.
Participants:One hundred and thirty-five eligible participants will be randomly assigned to a control group, receiving unfortified complementary food and to an experimental group receiving fortified complementary food for the duration of 6 months. Primary outcome of the study is to see improvement in body iron store as measured by Hemoglobin, S Ferritin, S Iron, TIBC and S Zinc and Secondary Outcome is improvement in growth in terms of weight, length and head circumference and Neurodevelopment Assessment using the Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III)
Expected Outcome:To achieve optimal growth in infants with cleft lip and palate and be ready for timely surgery, it is critical to implement appropriate nutrition interventions and nutrition education to the family. It’s a study protocol and expecting a change in body iron stores by 20% and improvement in growth and neurodevelopment of the infant with cleft.
Ethics and Dissemination:This study is approved by Institute’s Ethics Committees. The results will be disseminated through peer-reviewed publications and presentations targeting the global and local research communities. Trial registration number: CTRI/2022/11/047579.