Clinical trial NCT03466853: Assessment by the CANS Score Versus Anthropometry and Impact on Early Neonatal Morbidities
Official title: Assessment by the CANS Score Versus Anthropometry and Impact on Early Neonatal Morbidities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Malnutrition
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 300
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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)

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

Primary outcomes:
measure: infant nutritional status
timeFrame: Within the 1st 48 hours of birth
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: professor
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References: