跳至主要内容
临床试验/CTRI/2024/09/074097
CTRI/2024/09/074097尚未招募不适用

Effectiveness of Kangaroo Mother Care on Preterm babies in Tertiary care hospital: A Randomized controlled trial

Dr CHINNADURAI M1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
88
试验地点
1
主要终点
1.Average weight gain

研究概览

简要总结

After taking clearance from Institutional Ethics Committee, Rohilkhand Medical College and Hospital, Bareilly, the study will be conducted.

ï‚· Written informed consent will be taken from parents/guardians of all the patients participating in the study in a language they can understand. Anonymity will be proposed as optional and confidentiality will be maintained.

ï‚· All babies fulfilling inclusion criteria randomized in two groups:

Group 1: KMC group -Kangaroo mother care with normal routine NICU care

Group 2: Control group –Routine new born care

For randomization, we use computer generated random numbers.

Blinding: The sealed envelope will be opened by the staff on duty under the supervision of study doctor. The interventions which will be written on the slip will be carried out by the resident doctors and staff on duty not involved in the study.

INTERVENTION-Residents doctors and staff involved in KMC of neonates trained for Kangaroo mother care by showing live demonstration of KMC by primary investigators and showing a video produced by World Health Organization in collaboration with AIIMS, New Delhi. Randomly allocated intervention group neonates with KMC during KMC position by trained staff and resident doctors according to the treatment orders and protocols specified in AIIMS NICU protocol. KMC in KMC group neonate provided for maximum possible duration in a day till mother will be comfortable [minimum 4 hours per day].

ï‚· A comfortable environment will be provided for mothers by wearing hospital clothes after washing their hands, keeping the opening in front, and then lying on the bed and head elevated to a 45° angle to provide a comfortable reclining position. In order to emphasize skin-to-skin contact, the newborn was then placed on the mother’s bare chest while only wearing a diaper, socks, cap, and mittens. In order to maintain the newborn’s open airway and promote mother-child eye contact, a soft blanket was placed around the mother and child. To help with KMC, the mother’s hands were placed over the blankets and gently pressed against the neonate’s back to stabilize them.

ï‚· Determine a time that’s suitable for the mother and the baby when the child is ready for KMC. The early sessions are crucial and require for a lot of interactions. Explain her how to adhere to the KMC process patiently, gently, and with compassion. Invite her to bring her husband, mother-in-law, or any other family member. It contributes to the family’s positive mental state and guarantees the mother’s support.

Short: 4 hours a day.

Extended: five to eight hours per day.

Length: nine to twelve hours every day.

Continuous: More than twelve hours per day recorded for at least two days consecutively or more before being discharged.

ï‚· KMC is linked to a lower incidence of serious illnesses in neonates, such as pneumonia. KMC has been found to be more effective than incubator care for stable newborns in the majority of studies. This is because KMC encourages greater maternal and family involvement in care, provides adequate thermal care, reduces nosocomial infections, improves exclusive breastfeeding and weight gain, and is less expensive than incubator care. The baby’s five senses are fully satisfied by KMC. The baby listens to her mother voice and has skin-to-skin contact (touch) to sense the warmth of her mother, listens to her voice and heartbeat (hearing), sucks breast milk (taste) has eye contact with her (vision) and smells her odor (olfaction)

ï‚· Following that, a pulse oximetry probe will be attached to the neonate’s right wrist prior to feeding in order to measure vital signs like heart rate and oxygen saturation. For an entire one minute, the respiratory rate was recorded. ï‚· Finally after 30 minutes of feed administration and KMC neonates’ physiological parameters and feeding intolerance parameters were assessed including any feed regurgitation and abdominal distension. KMC was continued for maximum possible duration. Feed intolerance and NEC grading was defined based on AIIMS NICU protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
0.00 Day(s) 至 9.00 Month(s)(—)
性别
All

入选标准

  • All Hemodynamically stable preterm neonates admitted in NICU and Postnatal ward after delivery at Rohilkhand Medical College and Hospital.

排除标准

  • 1.Neonates with major congenital malformation.
  • 2.Perinatal Asphyxia [HIE II/HIE III].
  • 3.Intraventricular Hemorrhage greater than 2 grade.
  • 4.Neonates requiring any surgical intervention.

结局指标

主要结局

1.Average weight gain

时间窗: At the time of discharge, Patients anthropometric indices like weight, Length and head circumference will be recorded. Then | patients will be followed up in paediatric OPD at 6 weeks, 10 weeks and at 14 weeks of age and at 6 months of age. The weight, length and head circumference will be recorded with each follow up.

2.Frequency of feed intolerance in terms of feed regurgitation and abdominal distention

时间窗: At the time of discharge, Patients anthropometric indices like weight, Length and head circumference will be recorded. Then | patients will be followed up in paediatric OPD at 6 weeks, 10 weeks and at 14 weeks of age and at 6 months of age. The weight, length and head circumference will be recorded with each follow up.

3.Presence of necrotizing enterocolitis

时间窗: At the time of discharge, Patients anthropometric indices like weight, Length and head circumference will be recorded. Then | patients will be followed up in paediatric OPD at 6 weeks, 10 weeks and at 14 weeks of age and at 6 months of age. The weight, length and head circumference will be recorded with each follow up.

4.Duration of Hospital stay

时间窗: At the time of discharge, Patients anthropometric indices like weight, Length and head circumference will be recorded. Then | patients will be followed up in paediatric OPD at 6 weeks, 10 weeks and at 14 weeks of age and at 6 months of age. The weight, length and head circumference will be recorded with each follow up.

5.Vital parameters (Heart Rate, Respiratory Rate, SpO2)

时间窗: At the time of discharge, Patients anthropometric indices like weight, Length and head circumference will be recorded. Then | patients will be followed up in paediatric OPD at 6 weeks, 10 weeks and at 14 weeks of age and at 6 months of age. The weight, length and head circumference will be recorded with each follow up.

次要结局

  • Duration of Hospital stay(At the time of discharge, Patients anthropometric indices like weight, Length & head circumference will be recorded. Then patients will be followed up in paediatric OPD at 6 weeks, 10 weeks & at 14 weeks of age & at 6 months of age. The weight, length & head circumference will be recorded with each follow up.)

研究者

发起方
Dr CHINNADURAI M
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr CHINNADURAI M

ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,BAREILLY

研究点 (1)

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