跳至主要内容
临床试验/CTRI/2023/04/052060
CTRI/2023/04/052060尚未招募不适用

Impact of continuous kangaroo mother care initiated immediately after birth(iKMC) on newborns with birth weight between 1 to 1.5kg

Maanasa G1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Impact of immediate KMC vs Neonatal Intensive Care using warmer in preterm infants weighing (1-1.5kg) on early neonatal mortality, in a tertiary care hospital

研究概览

简要总结

Mother infant pair who meets the eligibility criteria will be enrolled into the study after obtaining written informed consent from pregnant mothers in the labour room. Consenting mothers are asked to identify one or two adult relatives or friends of their choice who could act as their surrogates for providing SSC when and if they are not able to do so. Surrogates have their role in the study explained to them if the mother–infant pair is randomly assigned to the intervention group.

If the infant is allocated to the intervention group, the nurse who attends all deliveries of potential babies helps the mother (or the surrogate in case the mother is indisposed) to initiate KMC as soon as possible after randomization. Monitoring of oxygen saturation and heart rate is carried out by using a pulse oximeter. The nurse also helps to transfer the mother (or surrogate) and the baby to the NICU in SSC. The researcher continues to support the mother or surrogate to provide continuous KMC after the baby is admitted to the NICU.

The infant is kept in SSC (atleast 12hrs per day) as much as possible, preferably with the mother but with a surrogate for the time when the mother cannot provide the intervention. In KMC, the infant is put naked on the mother’s chest. The infant has a cap, diaper, and socks and is secured firmly to the chest with a binder that ensures a patent airway and a shirt that provides containment in the fetal position. All routine care is provided in SSC. Any interruptions in SSC are documented to determine the duration for which the intervention was provided per day. The nurse also supports the mother in early expression of milk and to help the baby suckle at the breast.

If the infant is allocated to the control group, routine care is provided by hospital staff. The infant is transferred to the NICU in a radiant warmer as soon as possible. When discharged from the delivery room or operation theatre, the mother is transferred to the postnatal ward and the infant remains in the NICU in accordance with current guidelines. When the infant is ready to be fed, the mother provides expressed breast milk. After the stabilisation of the infant , the mother provides KMC as per the current WHO guidelines

In both the groups, infant in the NICU is monitored, and information regarding temperature, heart rate, respiratory rate anthropometry and oxygen saturation is recorded every 6h. Blood sugar similarly is monitored every 6h during the first 24h after birth and thereafter as and when required. In the KMC ward, infants are evaluated every 12 h up to hospital discharge. Measures will be taken to avoid contamination and special care would be taken to separate them. All other nursing care will be same for both the groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
1.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • •All infants born alive in the participating hospitals with a birth weight from 1.0 to less than 1.5 kg, regardless of their gestational age, are eligible for participation in this trial with their mothers.
  • •It should be a singleton pregnancy.
  • •The mother–infant pair is eligible even if the mother experiences some complications during labour and delivery that are expected to be resolved within 3 days.

排除标准

  • •1.The mother is younger than 15 years of age 2.The mother is unable or unwilling to provide consent 3.The mother is unlikely to be able to provide KMC initiation within the first 3 days after birth (eg: eclampsia or shock or has undergone major surgery) 4.Baby is unable to breathe spontaneously within 1 hour of birth 5.Baby on ventilatory support 6.Multiple gestation 7.Baby has a congenital malformation that interferes with the intervention or the intervention interferes with the care for the congenital malformation 8.If for any other reason the mother infant pair cannot be enrolled within 2 hours of birth of infant.
  • •9.If mother not able to provide immediate KMC or willing relative.

结局指标

主要结局

Impact of immediate KMC vs Neonatal Intensive Care using warmer in preterm infants weighing (1-1.5kg) on early neonatal mortality, in a tertiary care hospital

时间窗: Jan 2023-Jan 2024

次要结局

  • To determine the effect of the intervention on:(1.Time taken for physiological stabilization)

研究者

发起方
Maanasa G
申办方类型
Other [self]

研究点 (1)

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