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Assessment by the CANS Score Versus Anthropometry and Impact on Early Neonatal Morbidities

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ClinicalTrials.gov Identifier: NCT03466853
Recruitment Status : Unknown
Verified March 2018 by Ahmed Maged, Cairo University.
Recruitment status was:  Recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Study Description
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Brief Summary:
Assessment of malnutrition within 48 hours of birth through anthropometric indices as Weight, Length and Head circumference, Proportionality indices as MAC/HC ratio, Ponderal index and Body mass index, Clinical assessment of nutritional status (CANS) score. Detection of early neonatal morbidities within the first week of life including Hypoglycemia ,Polycythemia, Respiratory Distress Syndrome, Neonatal sepsis, Hyperbilirubinemia and Feeding intolerance

Condition or disease Intervention/treatment
Fetal Malnutrition Diagnostic Test: Clinical assessment of nutritional status (CANS) score Diagnostic Test: Anthropometric indices Diagnostic Test: Proportionality indices

Detailed Description:

Within the 1st 48 hours of birth, all live born, singleton neonates with gestational ages between 28-40 weeks will be included in the study after obtaining an informed consent from their legal guardians.

Assessment of malnutrition within 48 hours of birth:

  1. Anthropometric indices:

    Weight (using the infant weighing scale). Length (using the infant measuring board). Head circumference (using non-metallic non-stretchable tape).

  2. Proportionality indices:

    MAC/HC ratio (Calculation for each infant and value will be plotted on and compared with a standard curve). Ponderal index Body mass index

  3. Clinical assessment of nutritional status (CANS) score:

A total score <25 is considered as fetal malnutrition. 3. Detection of early neonatal morbidities within the first week of life (for those who will require NICU admission):

  1. Hypoglycemia (Random blood sugar)
  2. Polycythemia (Hematocrit level)
  3. Respiratory Distress Syndrome
  4. Neonatal sepsis (Clinically, Laboratory: CBC with diff., CRP, C/S)
  5. Hyperbilirubinemia (Serum bilirubin level, Need of phototherapy or exchange transfusion)
  6. Feeding intolerance (Abdominal distension with prominent intestinal loops, Gastric residue more than 3ml/kg before feeding at least 2 times/ day)
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment by the CANS Score Versus Anthropometry and Impact on Early Neonatal Morbidities
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Clinical assessment of nutritional status (CANS) score
    Systematized inspection and estimation of loss of SC tissues and muscles of nine superficial physical parameters including hair and buccal fat in the cheeks, chin and neck, arms, back, inter or subscapular skin, buttocks, legs, chest, and abdominal wall skin. These signs will be rated from 1 (worst, severe FM) to 4 (best, well nourished), and the highest and lowest total scores are 36 and 9, 3respectively. A total score of <25 is considered as fetal malnutrition.
  • Diagnostic Test: Anthropometric indices
    weight, length and head circumference
  • Diagnostic Test: Proportionality indices
    MAC/HC ratio (Calculation for each infant and value will be plotted on and compared with a standard curve). Ponderal index . A PI <2.2 is considered as malnutrition). Body mass index (BMI= weight (kg) / length2 (m). A BMI <11.2 kg/m2 is considered as malnutrition)

Outcome Measures
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Primary Outcome Measures :
  1. infant nutritional status [ Time Frame: Within the 1st 48 hours of birth ]
    To compare the assessment of infant nutritional status using the CANS score against anthropometric and proportionality indices


Eligibility Criteria
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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All neonates delivered at Kasr Al-Ainy Gynecology and Obstetrics department, Faculty of Medicine, Cairo University within the proposed study duration Within the 1st 48 hours of birth, all live born, singleton neonates with gestational ages between 28-40 weeks will be included in the study after obtaining an informed consent from their legal guardians
Criteria

Inclusion Criteria:

Neonates of both genders. Gestational age between 28-40 weeks. Singleton pregnancies.

Exclusion Criteria:

Presence of congenital anomalies. Infants of diabetic mothers

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466853


Contacts
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Contact: Ahmed Maged, MD +2001005227404 prof.ahmedmaged@gmail.com
Contact: Sherif Anwary, MD sherif_elanwary@hotmail.com

Locations
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Egypt
Kasr Alainy medical school Recruiting
Cairo, Egypt, 12151
Contact: Ahmed Maged, MD    01005227404    prof.ahmedmaged@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD professor
More Information
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Responsible Party: Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03466853    
Other Study ID Numbers: 33
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fetal Nutrition Disorders
Malnutrition
Nutrition Disorders
Fetal Diseases
Pregnancy Complications