A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial.

BACKGROUND: Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment. METHOD: The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site. DISCUSSION: We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe. TRIAL REGISTRATION: ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php -use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).

Could maternal stress be a causal factor for nonsyndromic cleft lip and/or palate: A retrospective study.

Background: The etiology of the nonsyndromic cleft lip and palate is multifactorial and not clearly defined. Objective: To determine whether maternal stress could be a causal factor for the occurrence of nonsyndromic cleft lip and palate. Materials and Methods: We conducted a retrospective observational study in which data from 50 mothers of children born with nonsyndromic cleft lip and palate and 50 mothers of noncleft children were analyzed. The outcomes defined were to study the association between the increased stress scores and the occurrence of nonsyndromic cleft lip and/or palate. Statistical analysis was performed using the Chi-square test. Results: The association between the high maternal stress scores and the occurrence of nonsyndromic cleft lip and/or palate was not found to be significant (P = 0.3220). A significant association was noted between increased maternal age and increased stress levels in the cleft group (P = 0.0001). Conclusion: No significant association was found between the increased stress scores and the occurrence of nonsyndromic cleft lip and/or palate. However, mothers of cleft children whose age was 35 years and above at the time of conception were noted to have higher stress levels.

A new tailored technique of vermilion repair in unilateral cleft lip.

The deficiency of vermilion on the medial side of the cleft can be augmented by procedures using excess vermilion from the lateral side as described in various other studies.(1) Here we present a technique of vermilion repair in unilateral cleft lip which is a modification of our earlier-described, V-advancement technique based on sound geometrical principles.(2) The new modification was assessed by comparing the results of 40 consecutive cases operated by this technique with 40 cases operated by the earlier-described technique. The surgical outcome as assessed by a panel was found to be significantly better with the newer technique. This technique is much simpler and overcomes some of the shortcomings of the previous technique at the same time retaining its benefits.

Isolated complete cleft.

Cleft sternum is a rare congenital anomaly due to failure of fusion of the sternal bone. The etiology of this defect is not well understood. The anomaly is more common in females and may be associated with Cantrell's pentalogy. It can be partial or complete. An 8-year-old female child presented with complete defect in the sternum which was confirmed with a chest radiograph and computed tomography. Only 24 cases of isolated complete cleft sternum have been reported so far. The treatment ranges from primary closure of the defect to the use of various autologous and prosthetic grafts. Our patient was treated with primary closure of the defect.

Attitudes of pregnant women and mothers of children with orofacial clefts toward prenatal diagnosis of nonsyndromic orofacial clefts in a semiurban set-up in India.

OBJECTIVES: To assess the attitudes of pregnant women and mothers of children with orofacial clefts toward prenatal diagnosis of clefts and elective termination of pregnancy, and to investigate their opinion about who makes reproductive decisions in the family. DESIGN: Two hundred subjects were included in the study prospectively regarding hypothetical prenatal ultrasound diagnosis of clefts. SETTING: The study was done in a private tertiary care institution and a teaching hospital. SUBJECTS/PARTICIPANTS: One hundred pregnant women consulting the Obstetrics department and 100 mothers of children with orofacial clefts in the Cleft and Craniofacial Unit were selected. MATERIALS AND METHODS: Group I subjects were interviewed using a questionnaire and were shown preoperative and postoperative pictures of children treated for cleft lip and palate. Group II subjects were interviewed using a questionnaire. RESULTS: Only 3% of Group I subjects and 2% of Group II opined that they would choose the elective termination of pregnancy if the fetus was diagnosed with a cleft on an ultrasound scan. In Group II, 70% subjects wished to have known about pregnancy affected with cleft prenatally and 96% said they would definitely avail ultrasound scans to determine pregnancy affected by clefts in future. CONCLUSIONS: Majority of the respondents from both the groups chose to continue with the pregnancy affected with a cleft when questioned regarding hypothetical prenatal ultrasound diagnosis of the cleft.

Enteral glutamine supplementation reducing infectious morbidity in burns patients: a randomised controlled trial.

PURPOSE: Enteral glutamine supplements have been shown to reduce infectious morbidity in trauma patients, but their effect on patients with burns is not completely studied. The objective of this study was to measure the impact of enteral glutamine supplementation on infectious morbidity and in turn, the hospital-stay in patients with burns. METHODS: Thirty patients with burns were randomly divided into two groups with 15 patients in each, the study (glutamine supplemented) and control group. Patients were randomised to receive either isonitrogenous mixture without glutamine or isonitrogenous mixture with glutamine until complete healing of the burn wound occurred. Incidence of positive blood culture, wound culture, total leucocyte count, hospital-stay and mortality was recorded. RESULTS: The results showed that the incidence of positive blood culture was considerably reduced in the study group (0.20±0.41) vs. control (0.73±0.96; p = 0.065). The incidence of positive wound culture was significantly reduced in the study group (1.00 ± 1.25) vs. control (3.53 ± 2.47; p = 0.001). In addition, the wound healing was better and hospital-stay days were reduced in the study group (22.73 ± 9.13 days) vs. (39.73 ± 18.27 days; p = 0.003). CONCLUSIONS: These results indicate that enteral glutamine supplementation in adult burn patients could abate the degree of infectious morbidity and reduce hospital-stay.

Supernumerary nostril with complete unilateral cleft lip: a case report and review.

The supernumerary nostril is an extremely rare congenital anomaly of duplication. A review of the literature shows that only 17 cases have been reported in the world. The supernumerary nostril in association with facial clefting is even more rare, with only three cases reported so far. We are reporting a case of supernumerary nostril in association with complete unilateral cleft lip without cleft palate, which happens to be the first case of its kind to be reported. Most supernumerary nostrils are situated superior to the normal nostrils and very few of them are situated at the same level or below the normal nostrils. In this case, the supernumerary nostril was placed lateral to the normal nostril.

A geometrically sound technique of vermilion repair in unilateral cleft lip.

In unilateral cleft lip, there is always a deficiency of vermilion on the medial side of the cleft, which can be augmented by techniques using excess vermilion from the lateral side of the cleft, like the use of a simple V-advancement flap. We developed a modification of Noordhoff's lateral vermilion flap that preserves the parallel relationship of the muco-vermilion line and the white roll but improves results in unilateral cleft lip patients. In a study of 30 patients undergoing surgical repair of complete unilateral cleft lip, we found that this method offers a superior alternative to the straight-line repair. This geometrically sound technique for vermilion reconstruction offers the cleft surgeon a simple and effective method for augmenting total lip height and creating a normal appearing Cupid's bow.