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

Fetal Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03466853
• Other study ID #: 33
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2018
• Last updated: March 9, 2018
• Start date: January 3, 2017
• Est. completion date: May 2018

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: +2001005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Presence of congenital anomalies. Infants of diabetic mothers

Related Conditions & MeSH terms

• Fetal Malnutrition
• Malnutrition

Intervention

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.
• Anthropometric indices
weight, length and head circumference
• 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)

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infant nutritional status	To compare the assessment of infant nutritional status using the CANS score against anthropometric and proportionality indices	Within the 1st 48 hours of birth