Fetal MalnutritionNCT03466853
Assessment by the CANS Score Versus Anthropometry and Impact on Early Neonatal Morbidities
An observational study of Fetal Malnutrition, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages Up to 2 days
- Conditions the study is for
- Fetal Malnutrition
- What is being tested?
- Clinical assessment of nutritional status (CANS) score, Anthropometric indices and Proportionality indices
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2017to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 days
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- Neonates of both genders. Gestational age between 28-40 weeks. Singleton pregnancies.
Who cannot join
- Presence of congenital anomalies. Infants of diabetic mothers
Trial locations and contacts
1 site in 1 country.
Sherif Anwary, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12151
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
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:
- Anthropometric indices: Weight (using the infant weighing scale). Length (using the infant measuring board). Head circumference (using non-metallic non-stretchable tape).
- 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
- 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):
- Hypoglycemia (Random blood sugar)
- Polycythemia (Hematocrit level)
- Respiratory Distress Syndrome
- Neonatal sepsis (Clinically, Laboratory: CBC with diff., CRP, C/S)
- Hyperbilirubinemia (Serum bilirubin level, Need of phototherapy or exchange transfusion)
- Feeding intolerance (Abdominal distension with prominent intestinal loops, Gastric residue more than 3ml/kg before feeding at least 2 times/ day)
- Conditions
- Fetal Malnutrition
- Being tested
- Clinical assessment of nutritional status (CANS) score, Anthropometric indices, Proportionality indices
- Medical subject headings
- Fetal Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessment of nutritional status (CANS) scoreDiagnostic test
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 indicesDiagnostic test
weight, length and head circumference
Proportionality indicesDiagnostic test
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
infant nutritional status
To compare the assessment of infant nutritional status using the CANS score against anthropometric and proportionality indices
Measured: Within the 1st 48 hours of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start3 Jan 2017
- Primary completionApr 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal MalnutritionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466853
- Sponsor's protocol ID
- 33
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment by the CANS Score Versus Anthropometry and Impact on Early Neonatal Morbidities
- ClinicalTrials.gov ID
- NCT03466853
- Acronym / sponsor ID
- 33
- Conditions
- Fetal Malnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Anthropometric indices: Weight (using the infant weighing scale). Length (using the infant measuring board). Head circumference (using non-metallic non-stretchable tape).
- 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
- 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):
- Hypoglycemia (Random blood sugar)
- Polycythemia (Hematocrit level)
- Respiratory Distress Syndrome
- Neonatal sepsis (Clinically, Laboratory: CBC with diff., CRP, C/S)
- Hyperbilirubinemia (Serum bilirubin level, Need of phototherapy or exchange transfusion)
- Feeding intolerance (Abdominal distension with prominent intestinal loops, Gastric residue more than 3ml/kg before feeding at least 2 times/ day)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- Neonates of both genders. Gestational age between 28-40 weeks. Singleton pregnancies.
Key exclusion criteria (1 listed)
- Presence of congenital anomalies. Infants of diabetic mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical assessment of nutritional status (CANS) scoreSystematized 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 indicesweight, length and head circumference | Diagnostic test | – |
| Proportionality indicesMAC/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) | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Fetal Malnutrition
Active, not recruiting
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif Anwary, MD contact
Ahmed Maged, MD principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Malnutrition, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (+2001005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infant nutritional status (time frame: Within the 1st 48 hours of birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.