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

NCT ID: NCT03466853

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-03
• Study Completion Date: 2018-05-31

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

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)

Conditions

Fetal Malnutrition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Anthropometric indices

weight, length and head circumference

Intervention Type: 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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Maximum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maged

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

Kasr Alainy medical school

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Maged, MD

Role: CONTACT

prof.ahmedmaged@gmail.com

+2001005227404

Sherif Anwary, MD

Role: CONTACT

sherif_elanwary@hotmail.com

Facility Contacts

Ahmed Maged, MD

Role: primary

prof.ahmedmaged@gmail.com

01005227404

Other Identifiers

33

Identifier Type: -

Identifier Source: org_study_id