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Status unknownNCT03466853Updated Mar 15, 2018

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

An observational study in Fetal Malnutrition, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged Up to 2 Days. Per ClinicalTrials.gov, last updated 2018-03-15.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
300
Ages
Up to 2 Days
Sex
All
01

Study 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

Read the 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)
02

Conditions studied

  • Fetal Malnutrition

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03

Who can participate

Ages eligible
Up to 2 Days
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Presence of congenital anomalies. Infants of diabetic mothers

04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testClinical 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 testAnthropometric indices

    weight, length and head circumference

  • Diagnostic testProportionality 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)

05

What researchers measure

Primary outcomes

  1. infant nutritional status

    To compare the assessment of infant nutritional status using the CANS score against anthropometric and proportionality indices

    Time frame: Within the 1st 48 hours of birth

06

Study locations

1 of 1 sites recruiting
  • Kasr Alainy medical school
    Cairo, 12151, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03466853
Lead sponsor
Cairo University
Responsible party
Ahmed Maged (professor, Cairo University) — Principal investigator
First posted
Mar 15, 2018
Start date
Jan 3, 2017
Primary completion
Apr 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Mar 15, 2018

Study contacts

Ahmed Maged, MD
Contact
prof.ahmedmaged@gmail.com
+2001005227404
Sherif Anwary, MD
Contact
sherif_elanwary@hotmail.com
Ahmed Maged, MD
principal investigator · professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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