NCT03206424

Brief Summary

WHO and UNICEF recommend exclusive breastfeeding for six months and addition of complementary foods (CF) at six months of age with continued breastfeeding till two years But WHO estimates that 2 out of 5 children are stunted in low-income countries, so CF should be timely, adequate and prepared and given in a safe manner.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Status
unknown

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

June 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

June 27, 2017

Last Update Submit

January 9, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • A questionnaire developed following the guidelines of WHO for CF practices, is used for collecting data through face-to-face interviews with mothers in the health centers.

    Specific values taken by good history from mother of the index infant including: 1. When and why did the mother start complementary feeding? 2. What is the type of food? 3. How much food taken in one meal and How many meals are taken within the day? 4. How does she prepare and give this food? 5. What the effect of this food on breastfeeding demand or frequency? 6. Ask about incidence and frequency of problems related to beginning of complementary food such as attacks of Acute gastroenteritis, Constipation or Acute chest infection. 7. Information about the index infant: name, age, sex, his/her order in the family, height and weight of child at birth. 8. General information about the parents such as name, age, place of residence, educational level, occupational status, socioeconomic level, self-hygiene and number of children of the family. Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17

    16 months

  • Growth parameters

    1. Weight for age percentile. 2. Height / Length for age percentile. 3. Weight for Height percentile. 4. Head Circumference for age percentile. Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17

    16 months

  • Motor development parameters

    Motor development milestones will be measured according to the infant actual age: 1. Head support. 2. Sitting. 3. Standing. 4. Walking. 5. Running. Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17

    16 months

  • Mental development parameters

    Mental development milestones will be measured according to the infant actual age: 1. Follows moving objects and light. 2. Laughs loudly and prefers social content. 3. Recognizes and prefers mother. 4. Says "Mama, Dada". 5. Speaks first real word. 6. Speaks 10-15 words. 7. Speaks 2- 3 word sentences. Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17

    16 months

Eligibility Criteria

AgeUp to 2 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

collecting data through face-to-face interviews with mothers in the health centers for good history and assessment of the infant growth and development.The index cases visiting our hospital and other local public health centers for various reasons such routine check-ups, vaccinations or illness are recruited in the study.

You may qualify if:

  • Infants (Age \< 2 years).
  • Full Term and Appropriate for Gestational Age (AGA).
  • Infants with successful breastfeeding.

You may not qualify if:

  • Children (Age\> 2 years). 2. Preterm infants, Small for Gestational Age (SGA) or Intrauterine Growth Retardation (IUGR).
  • \. Infants with chronic illness, intrauterine infection and major congenital anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Saleh F, Ara F, Hoque MA, Alam MS. Complementary feeding practices among mothers in selected slums of Dhaka city: a descriptive study. J Health Popul Nutr. 2014 Mar;32(1):89-96.

  • Batal M, Boulghourjian C, Akik C. Complementary feeding patterns in a developing country: a cross-sectional study across Lebanon. East Mediterr Health J. 2010 Feb;16(2):180-6.

  • WHO Multicentre Growth Reference Study Group. Complementary feeding in the WHO Multicentre Growth Reference Study. Acta Paediatr Suppl. 2006 Apr;450:27-37. doi: 10.1111/j.1651-2227.2006.tb02373.x.

  • Davies-Adetugbo AA, Adetugbo K. Effect of early complementary feeding on nutritional status in term infants in rural Nigeria. Nutr Health. 1997;12(1):25-31. doi: 10.1177/026010609701200103.

Related Links

Study Officials

  • Hanaa M Abdellatif, professor

    Assuit University- pediatric hospital

    STUDY CHAIR
  • Osama M Al-asheer, professor

    Assuit University - pediatric hospital

    STUDY DIRECTOR
  • Ahmed M Abdullah, resident

    Assuit University - pediatric hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed maher, resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2017

First Posted

July 2, 2017

Study Start

February 1, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

January 10, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share