Comparing the power of breast milk VS glusose solution in reducing the pain during treatment.
- Conditions
- Endocrine, nutritional and metabolic diseases,
- Registration Number
- CTRI/2021/09/036220
- Lead Sponsor
- Yuvasri Alias Shanthini
- Brief Summary
This is a prospective randomized controlled trial. A sample of 72 neonates between the gestationalage of ≥34 to ≤42 weeks will be taken and are randomized into 2 groups by computer generatednumbers. After obtaining informed written consent from the parents, neonates will be included inthe study. Gestational age is confirmed with modified Ballard scoring. Before 30 seconds of heelprick, One group of neonate is administered 1ml of 10% dextrose by 2ml sterile syringe and othergroup is administered 1ml of Expressed Breast Milk by 2ml sterile syringe of the respective motherby the principal investigator. With the baby lied on the radiant warmer, It is given per oral drop bydrop on the anterior aspect of tongue with the baby in supine position. 30 sec after administrationof the dextrose or Expressed Breast Milk, heel prick is done in the lateral aspect of the heel with a gun needle andresponse to procedural pain is being assessed by Premature Infant Pain Profile score at 0s, 30s, 60s after heel prick. Twoindependent observers are chosen.Observer 1: An intern will be videotaping the facial and behavioral changes in the neonate i.e.after instillation of the solution to the baby to 60sec after heel prick.
Observer 1: An intern will be videotaping the facial and behavioral changes in the neonate i.e.after instillation of the solution to the baby to 60sec after heel prick.Observer 2: A Post graduate resident shall record HR, SPO2 saturation of the neonate from themultiparameter monitor. Baseline value and at 0s, 30s and 60s after heel prick are noted.Outcome variables are measured by Premature Infant Pain Profile score.8 PIPP is the reliablemeasure of pain with a minimum score of 0 and maximum score of 21.It includes 7 indicators. 2 contextual (Gestational age, Behavioral state) 2 physiological (Changein heart rate, Change in oxygen saturation) 3 behavioral (Brow bulge, Eye squeeze, nasolabialfurrow). Scores ranges from 0, +1, +2, +3 for each indicator. In general <6 is minimal pain. >12is moderate to severe pain. Maximum PIPP score is 21 preterm babies, 18 for term babies.
Calculate the total score by adding subtotal score (physiological + facial indicators) and behavioralscore and the efficacy is interpreted. An independent observer will be analyzing the video and willscore all the videos in the end to avoid interobserver variation. The observer who interprets thevideo and records PIPP score, will be blinded on what intervention is given. Subgroup analyseswill be done at the end of the study.Scoring instructions for PIPP scoring1.Observe the baby for 15 sec at rest and asses the vital sign indicator. Highest Heart rate(HR), lowest spo2 saturation and behavioral state.2. Observe the infant for 0, 30sec ,60 sec following the painful event. Score physiologicand facial changes seen during this time and record immediately3. Score for corrected Gestational age (GA) and behavioral state (BS) assessment if thesubtotal is >05. Record full PIPP score. Calculate the score by adding Sub-total score and Behavioral score.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 72
- Neonates born between ≥34 to ≤42 weeks of Gestational age who have indication to undergo heel prick for capillary blood glucose estimation.
- Neonatal age since birth to less than or equal to 28days.
- Babies with Sepsis 2.
- Babies with congenital malformations 3.
- Babies under sedation 4.
- Neonates who are already crying 5.
- Babies passing urine or stools during the procedure 6.
- Babies on Nil Per Oral 7.
- 5mins APGAR of <7 8.
- Parents refusal to give consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of 10% Dextrose and Expressed breast milk on relieving o , 30 , 60 seconds procedural pain in neonates assessed by Premature Infant Pain Profile. Score less than 6 is mild and score more than 12 is moderate to severe pain. o , 30 , 60 seconds
- Secondary Outcome Measures
Name Time Method Through this research the procedural pain in neonates is being reduced by giving 10% dextrose and Expressed Breast Milk might decrease the possible neurodevelopmental damage produced due
Trial Locations
- Locations (1)
Sri Manakula Vinayagar Medical College and Hospital
🇮🇳Pondicherry, PONDICHERRY, India
Sri Manakula Vinayagar Medical College and Hospital🇮🇳Pondicherry, PONDICHERRY, IndiaYuvasri Alias ShanthiniPrincipal investigator8072330324shantu.smileplease@gmail.com