Rasiga Thivya, J S (2020) An Observational study to Compare Prophylactic and Therapeutic Surfactant Administration in Preterm Babies and Retinopathy of Prematurity. Masters thesis, Madurai Medical College, Madurai.
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Abstract
AIM AND OBJECTIVES: To compare Prophylactic versus Therapeutic surfactant administration in preterm babies and retinopathy of prematuriy. STUDY DESIGN: Prospective Observational study. STUDY CENTRE: • Department of Ophthalmology, Government Rajaji Hospital, Madurai. • Neonatal intensive care unit,Institute of Paediatrics, Government Rajaji Hospital, Madurai. STUDY DESIGN: Prospective Observational study. STUDY CENTRE: • Department of Ophthalmology, Government Rajaji Hospital, Madurai. •Neonatal intensive care unit,Institute of Paediatrics, Government Rajaji Hospital, Madurai. Informed Consent for the study is obtained in written statement from parents or guardian of all the babiesbefore enrolment for the study. SELECTION OF STUDY SUBJECTS: 100 babies fulfilling the eligibility criteria referred from Neonatology Intensive Care Unit, GRH, Madurai whom were given surfactant therapy. METHODOLOGY: The various parameters recorded were weight at birth, gestational age, age of post conception, risk factors such as anaemia, long term exposure to oxygen, neonatal jaundice, mechanical ventilation, use of any surfactant, Respiratory Distress Syndrome, sepsis, multiple births, multiple blood transfusions, and intraventricular haemorrhage. Gestational age was calculated according to last menstrual period or according to the date mentioned by first trimester USG abdomen. In our study the screening protocol for ROP was followed based on the guidelines by National Neonatology Forum (NNF). The first retinal examination would be held at 4 to 5 weeks from the birth. Retina examined with binocular indirect ophthalmoscope with+20 D lens. Patient information and retinal findings recorded in the ROP screening case sheet. For categorising ROP, revised ICROP guidelines and classification was used. Followup schedule individualised based on the retinal findings and it would be continued till retina vascularises completely or ROP regression noted or until treated according to the ETROP guidelines. In our study, “Mild ROP”- was termed for ROP where the severity is not sufficient to meet the criteria for treatment according to “ETROP” and CRYO-ROP study and, “Severe ROP”- was termed for either the Type 1 ROP based on “ETROP study” findings or the threshold ROP, Aggressive ROP, stage 4 ROP (partial RD) or stage 5 ROP(total RD) that validates treatment. Babies in our study will be categorised into two groups as follows: GROUP 1: Preterm low birth weight babies who received prophylactic surfactant therapy. GROUP 2: Preterm low birth weight babies who received therapeutic surfactant therapy. PROCEDURE: - Procedure explained to babie’s parents or the guardian. - Informed written consent to be obtained. - Oral feeds to be curtailed one hour before the procedure. - Clean hands with disinfectant is the priority. - Anterior segment of the eye would be examined before retinal examination to look for pupil size, tunica vasculosalentis, pupillary light reflex and lens status. - Both the eyes are dilated with the mydriatics, as a combination of tropicamide 0.5% and phenylephrine 2.5% eye drops has to be prepared by diluting tropicamide 0.8% and phenylephrine 5% eye drop in tear substitutes in 50:50, and used two to three times about 10-15 minutes apart. STATISTICAL ANALYSIS: The information collected regarding all the selected cases were recorded in a Master Chart. Data analysis was done with the help of computer by using SPSS 16 software. Using this software, percentages, means, standard deviations were calculated and 'p' values were calculated from Student ‘t’ test for raw data and chi square test for consolidated data to test the significance of difference between variables. A 'p' value less than 0.05 is taken to denote significant relationship SUMMARY OF RESULTS: Among 100 babies taken for the study, 20 had severe ROP ; 16 had mild ROP and 54 had No ROP. Among 100 babies analysed, 54 were males and 46 were females. Group 1 had 22 males and 22 females also Group 2 had 32 males and 24 females. There was no significant association of gender between the groups, since the ‘p’ value was 0.611. The mean gestational age in group 1 and group 2 were 30.818 weeks and 31.719 weeks respectively and there is no significant difference in gestational age between the two groups.(P = 0.242). The mean birth weight in group 1 and group 2 were 1.412 grams and 1.542 grams respectively and significant difference was found between the two groups.(P = 0.011). Among 100 babies, 58 were normal vaginal delivery and 32 were LSCS. Group 1 had 28 NVD cases and 16 LSCS cases and group 2 had 40 NVD cases and 16 LSCS cases. There was no significant association between two types of mode of delivery in both the groups. (P = 0.54) *In this study, prophylactic surfactant is given to 44 babies and therapeutic surfactant to 56 babies * In Group 1, among male and female occurrence of severity of ROP shows P value as 0.678 and in Group 2 its 0.406.both are not statistically significant. * In Group 1, occurrence of Severe ROP on comparing gestational age < 30 weeks and > 30 weeks shows p value 0.234. In Group 2, occurrence of severe ROP in group 2 shows p value 0.318.both are not statistically significant. In Group 1, occurrence of Severe ROP on comparing birth weight < 1.25 and > 1.25 shows p value 0.105. In Group 2, occurrence of sever ROP in group 2 shows p value 0.809.Both are not statistically significant. Among 100 babies, 20 were severe ROP cases, 16 mild ROP cases and 54 were No ROP cases. Group 1 had 2 severe ROP cases, 6 mild ROP cases, 36 No ROP cases .Group 2 had 18 severe ROP cases, 10 mild ROP cases and 36 No ROP cases. The incidence of severe ROP was found to be more among surfactant given babies. Statistical analysis showed, there is significant association between retinal findings in both the groups. (P < 0.001). CONCLUSION: Our study showed that babies who had prophylactic Surfactant administration compared to therapeutic surfactant administration showed reduced incidence in severity of ROP. When Surfactant administration is present in preterm low birth weight babies, and if its therapeutic also it should be considered as an independent risk factor for ROP. Followup and screening to be increased in babies who had therapeutic surfactant administration in postnatal period. When surfactant administered babies are screened for ROP regularly, it will help to detect the ROP timely and treatment can be delivered at its earliest. Thus reducing the devastating sequeale of ROP. It is also helpful to avoid unnecessary stressful examination on preterm infants who are not at risk of developing “severe ROP”. Our study result helps the ophthalmologists and the neonatologists to look into the surfactant administered babies with special care and attention ,and to predict and closely followup for retinopathy changes much earlier before it is being diagnosed by the regular ophthalmic examination .It will help to intervene early and to prevent sight threatening complications. This study shows significant association between therapeutic surfactant administration and severe ROP than prophylactic surfactant administration. Also shows the need for mechanical ventilation is more in therapeutic surfactant babies which can increase the risk of ROP.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | 221713105 |
| Uncontrolled Keywords: | Prophylactic and Therapeutic Surfactant Administration, Preterm Babies, Retinopathy, Prematurity. |
| Subjects: | MEDICAL > Ophthalmology |
| Depositing User: | Subramani R |
| Date Deposited: | 14 Feb 2021 09:34 |
| Last Modified: | 14 Feb 2021 09:34 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/14176 |
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