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临床试验/CTRI/2020/01/022796
CTRI/2020/01/022796已完成1 期

Effectiveness of modified Naso alveolar moulding appliance on feeding and Naso alveolar moulding in unilateral cleft lip and palate babies

Prinicipal InvestigatorDr Sangeetha M G1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月15日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Effective naso alveolar moulding and breast feeding

研究概览

简要总结

Cleft Lip and Palate is one of the most common craniofacial deformities occurring all over the world and has a higher ratio in India. Apart from serious problems like aspiration, infections, poor growth and development of the affected child, the family undergoes emotional struggles, postpartum depression of the new mothers, long term burden of care etc., Feeding the babies is one of the most important and immediate post-natal concern. Feeding plates, special bottles and nipples are available to facilitate feeding of cleft babies. Patients undergo many surgeries for correction of the cleft deformity from the age of 3 months. Reconstruction of the lips, palate and nose to normal anatomy is a challenge for surgeons. Presurgical Infant Orthopedics(PSO) was developed as an adjunct to the surgical management. Presurgical nasoalveolar moulding appliance (PNAM), a type of PSO was introduced by Grayson and Cutting, based on Matsuo’s cartilaginous moulding concept. This technique takes advantage of the malleability of immature cartilage and its ability to maintain a permanent correction of its form. The Primary goal of PNAM is to decrease the severity of the primary cleft deformity and provide symmetry to distorted nasal cartilage along with Nonsurgical lengthening of the columella. Approximation of lip segments and reduction of the cleft size decreases tension in the tissues during and after surgery reducing the severity of scarring. This produces a better surgical outcome of the lip repair and reduces the number of surgical revisions for nasal correction. Unlike other PSOs, NAM not only moulds the alveolar cartilage, but also the nasal cartilage, into near normal form and symmetry through a nasal stent.

These appliances generally facilitate feeding while reducing the cleft size. But, due to lack of complete oral seal, feeding especially breast feeding is still not completely effective with these babies. With the availability of newer materials like polyamide based denture materials, appliances can be made, to produce better intra oral suction facilitating easy feeding and more comfortability. This research on modified NAM appliance will not only improve alveolar and nasal moulding but also improve the baby’s overall growth and development with effective feeding while alleviating the apprehension of parents leading to a successful childhood.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
2.00 Day(s) 至 90.00 Day(s)(—)
性别
All

入选标准

  • non syndromic newborn unilateral cleft lip and palate babies.

排除标准

  • 1.syndromic cleft lip and palate patients 2.presentation with other medical condition.

结局指标

主要结局

Effective naso alveolar moulding and breast feeding

时间窗: At the start and At the End of 3 months/12 weeks.

次要结局

  • pycological improvement of mothers due to better breast feeding .(At the start and At the end of 12 weeks)

研究者

发起方
Prinicipal InvestigatorDr Sangeetha M G
申办方类型
Other [self]

研究点 (1)

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