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To,
The Ethical committee
The Children’s Hospital & The ICH Lahore
Sir,
I am doing Masters in Public Health from IPH Lahore. I am on deputation from The Children’s
Hospital & ICH Lahore where I was working as Deputy Medical Superintendent. I am planning for
research on Factors predisposing to cleft lip and palate in children as a part of fulfillment of my
Masters thesis. I need ethical approval for my research proposal.
Thanking you
Dr. Asad Zain
DMS CH & ICH
Dated: 6.9.2017

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FACTORS PREDISPOSING TO CLEFT LIP AND PALATE IN CHILDREN
Dr. Asad Zain
BACKGROUND:
The greatest asset of any country is the new generation of healthy intelligent and wise
children. This asset is made inefficient if the children are born with congenital malformations.
1
A
significant component of human birth defects comprises of craniofacial anomalies.
Second most
common entity in this group are Oral clefts.
2
Clefts of the lip and palate represent a heterogeneous
group of disorders affecting the lips and oral cavity and are generally divided into two groups,
isolated cleft palate and cleft lip with or without cleft palate. Orofacial clefts may involve the lip,
the roof of the mouth (hard palate), or the soft tissue in the back of the mouth (soft palate).
Oral, facial, and craniofacial deformity occur when there is involvement of these structures.
3
These defects arise in about 1.7 per 1000 live-born babies, with ethnic and geographic
variation.
4
The incidence varies by race, sex and geographic location.
Asians are at higher risk than
whites or blacks.
1
A research from Pakistan showed that out of total 61,156 births 117 children were
born with oral clefts with the incidence to be 1.91/1000 live births.
5
A review article revealed that
the prevalence of cleft lip and cleft palate was from 0.78 to 2.14 in Iranian children.
1
An environmental and complex multi-faceted genetic etiology is involved in oral clefts.
Oral cleft often occurs as a part of well- recognized syndromes but numerous risk factors are also
involved in the disease causal pathway. Maternal factors like smoking, anti-epileptic drugs usage,
congenital toxoplasmosis, rubella, cytomegalovirus, herpes simplex (TORCH) infections, nutritional
deficiencies of folic acid during pregnancy are the common risk factor along with consanguinity.
1
In
recent years very significant progress has been made with respect to genetic determinants and
a range of environmental risk factors for cleft lip and palate.
6

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1 To, The Ethical committee The Children’s Hospital & The ICH Lahore Sir, I am doing Masters in Public Health from IPH Lahore. I am on deputation from The Children’s Hospital & ICH Lahore where I was working as Deputy Medical Superintendent. I am planning for research on “Factors predisposing to cleft lip and palate in children” as a part of fulfillment of my Masters thesis. I need ethical approval for my research proposal. Thanking you Dr. Asad Zain DMS CH & ICH Dated: 6.9.2017 2 FACTORS PREDISPOSING TO CLEFT LIP AND PALATE IN CHILDREN Dr. Asad Zain BACKGROUND: The greatest asset of any country is the new generation of healthy intelligent and wise children. This asset is made inefficient if the children are born with congenital malformations.1 A significant component of human birth defects comprises of craniofacial anomalies. Second most common entity in this group are Oral clefts.2 Clefts of the lip and palate represent a heterogeneous group of disorders affecting the lips and oral cavity and are generally divided into two groups, isolated cleft palate and cleft lip with or without cleft palate. Orofacial clefts may involve the lip, the roof of the mouth (hard palate), or the soft tissue in the back of the mouth (soft palate). Oral, facial, and craniofacial deformity occur when there is involvement of these structures.3 These defects arise in about 1.7 per 1000 live-born babies, with ethnic and geographic variation.4 The incidence varies by race, sex and ge ...
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