STUDY OF BREAST MILK FOR PAIN RELIEF DURING TARGETED NEONATAL ECHOCARDIOGRAPHY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Comparison of PIPP-R scores between the two study group
研究概览
简要总结
This randomised controlled trial will be conducted on VLBW babies admitted in our unit & undergoing Tn-ECHO. The study will commence after approval from Institutional Ethics Committee (IEC).
The decision to do Tn-ECHO will be taken by the NICU team, according to institution protocols based on the the standard of care. Those babies satisfying the inclusion criteria will be enrolled after written informed consent from either parent. Babies will be randomized to receive either expressed breast milk (Group A) or no intervention (Group B). Blocked randomization will be done using computer generated random number sequencing using block sizes of 2 & 4. Allocation concealment will be done using serially numbered opaque sealed envelopes.
Procedure: Tn-ECHO examination will be done by senior neonatologist trained in basic neonatal ECHO. Sonosite Fujifilm 2D-ECHO machine will be used. Before examination all the noxious stimuli will be minimized. Babies in both groups will receive non pharmacological pain relief intervention in form of containment and facilitated tucking. Alarms of all equipments will be minimized. All subjects will be evaluated 5 minutes before Tn-ECHO for PIPP-R score & physiological parameters like HR, RR, spO2, PI (heart rate, respiratory rate, blood pressure, transcutaneous oxygen saturation, perfusion index) will be recorded. For behavioral components of PIPP-R score video recording will be done using a smart phone. Babies in Group A WILL RECEIVE 1ML/KG OF EXPRESSED BREAST MILK WHICH WILL BE SWABBED OVER THE BUCCAL MUCOSA. Babies randomized to Group B will receive no additional intervention. PIPP-R score & other physiological parameters will be recorded during the examination and 5 minutes after completion of Tn-echo examination. Behavioral score component of PIPP-R will be interpreted from the video recording by two independent neonatologists who will be blinded to the intervention.
Table 1: Physiological parameters of newborn related to tn-ECHO examination
| 5 mins Before examination |
During examination
5 mins after examination
|HR (per min)
|RR (per min)
|Spo2 (%)
|PI
|SBP (mmHg)
×
|DBP (mmHg)
×
|MAP( mmHg)
×
HR: Heart Rate, RR: Respiratory Rate, Spo2: Transcutaneous oxygen saturation pre-ductal, PI: Perfusion Index, SBP: systolic Blood Pressure, DBP: Diastolic Blood Pressure, MAP: Mean Arterial Pressure.
PIPP-R scoring figure taken from 2013 Lippincott Williams & Wilkins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All VLBW babies undergoing Tn-ECHO according to NICU protocol.All VLBW babies undergoing Tn-ECHO according to NICU protocol.
排除标准
- •1.Severe perinatal asphyxia 2.Neonatal encephalopathy 3.Major congenital malformation 4.Babies on drugs causing CNS depression.
结局指标
主要结局
Comparison of PIPP-R scores between the two study group
时间窗: Comparison of PIPP-R scores between the two study groups 5 minutes before, during and 5 minutes after echocardiography
次要结局
- Heart rate(Comparison of heart rate between the two study groups 5 minutes before, during and 5 minutes after echocardiography)
- Perfusion index(Comparison of perfusion index between the two study groups 5 minutes before, during and 5 minutes after echocardiography)
- Respiratory rate(Comparison of respiratory rate between the two study groups 5 minutes before, during and 5 minutes after echocardiography)
- Blood pressure(Comparison of blood pressure between the two study groups 5 minutes before and 5 minutes after echocardiography)