Can Kangaroo Mother Care (KMC) during the first 72 hours lead to improved breastfeeding and growth among normal birth weight newborns? - A randomized controlled trial.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 516
- 试验地点
- 6
- 主要终点
- 1) Percentage weight change over the first 48 hours after birth.
研究概览
简要总结
Suboptimal breastfeeding practices within the first week of an infants life may perpetuate a deleterious cycle of inadequate lactation and stunted growth. The initial challenges in thermoregulation and metabolism during the transition from intrauterine to extrauterine life within the initial 72 hours can also contribute to early weight loss in neonates. Kangaroo Mother Care (KMC) is a recommended practice for reducing mortality in low birth weight infants, and it may potentially enhance nutritional and growth outcomes in normal birth weight infants when initiated within the first 72 hours of life.
This multicenter, open-label, two-arm, individually randomized controlled trial will enroll infants born with a birth weight of 2500 grams or higher, without delivery complications. A total of 516 infants will be randomly assigned to either the intervention or control groups. Infants in the intervention group will receive extended KMC for the initial 48 hours, while control group infants will receive standard breastfeeding counseling. Assessments will be conducted on days 1, 2, 4, 7, 15, and 28 to evaluate study outcomes.
Kangaroo Mother Care (KMC) is a cost-effective innovation that involves skin-to-skin contact between the newborn and the mother or caregiver, combined with exclusive breastfeeding and additional supportive care. When KMC is initiated after clinical stability is achieved, it results in a 40% improved survival rate compared to traditional incubator care. Furthermore, when KMC is initiated before clinical stabilization, it accelerates the stabilization process and reduces neonatal mortality by an additional 25% compared to conventional incubator care before stabilization. This study in Uttar Pradesh is part of a broader multicenter initiative, involving multiple sites and close collaboration with the health system, research teams, and community stakeholders. The study in UP will be conducted in partnership with medical colleges, where obstetric and pediatric leadership will lead the integration of KMC within their facilities and support its wider adoption. The study will also require strong coordination with lower-level facilities to facilitate the early initiation of KMC for term, normal-weight infants.
In this study, we will enroll 516 singleton neonates with normal birth weight, defined as infants weighing 2500 grams or more at birth within the study facility. Following screening, infants will be randomized to the intervention or control groups immediately after birth, with randomization achieved through a concealed allocation based on a computer-generated sequence. Each motherinfant pair will receive a unique identification number.
Mothers of infants in the intervention group will receive education and counseling immediately after birth, emphasizing prolonged skin-to-skin contact in the KMC position during the initial 72 hours of life. This involves maintaining skin-to-skin contact for a minimum of 8 hours per day during their facility stay, along with on-demand breastfeeding. The duration of skin-to-skin contact can gradually extend and continue as long as the baby remains comfortable. Both the infant and mother will remain bare-chested in the KMC position, with the baby head covered by a cap and feet kept warm with socks. In the control group, mother-infant pairs will receive standard care, including general counseling on early and exclusive breastfeeding after birth.
We anticipate that early implementation of KMC has the potential to significantly enhance nutritional and growth outcomes in infants under 6 months and contribute to the standardization of newborn care protocols across different weight categories.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 27.00 Day(s)（—）
- 性别
- All
入选标准
- •Healthy singleton newborns with birth weight greater than equal to 2500 grams, born vaginally and screened and enrolled within 4 hours of birth.
- •2.Residing within the catchment area near the study facility
- •Having singleton vaginal births in the study facility without any complications
- •Willing to stay in the study facility for 48 hours post-delivery and continue recommended practices at home post-discharge
- •Provide written informed consent for study participation within 4 (four) hours of birth.
排除标准
- •Newborns: 1) Any condition that will require immediate admission to the neonatal intensive care unit (NICU/ SNCU) such as respiratory distress, birth asphyxia etc 2) Newborn should not be enrolled in any other research study that would interfere with the intervention and outcomes.
- •Having major congenital malformations which are apparent at birth that can interfere with the intervention like anencephaly, hydrocephalus, omphalocele, cleft lip, cleft palate, meningomyelocele, imperforate anus.
- •Mothers: 1) Maternal death 2) Multiple births 3) Caesarean section delivery 4)Women with HIV opting for top feeding 5) Any complications e.g. post partum haemorrhage (PPH), eclampsia, etc.
- •identified within an hour of birth, requiring special or intensive care beyond routine postnatal care 6) Any other problems, such as generalized skin rashes/ infection, that may hinder their ability to provide prolonged KMC.
结局指标
主要结局
1) Percentage weight change over the first 48 hours after birth.
时间窗: 1) 48 hours of birth | 2) After the newborn reaches 28 days of age | 3) After the newborn reaches 28 days of age
2) The weight gain velocity during the newborn period
时间窗: 1) 48 hours of birth | 2) After the newborn reaches 28 days of age | 3) After the newborn reaches 28 days of age
3) Quality of breastfeeding as measured through the Bristol Breastfeeding Assessment Tool (BBAT) score on Day 8
时间窗: 1) 48 hours of birth | 2) After the newborn reaches 28 days of age | 3) After the newborn reaches 28 days of age
次要结局
- Exclusive Breastfeeding at day 28 of birth(After the newborn reaches 28 days of age)
- Score on the Breastfeeding Experience Scale as reported by mother(At 8 days of birth)
- Possible Serious Bacterial Infection (PSBI) among infants(4, 8, 15 & 29 days of birth.)
- Maternal depression measured at 15days after birth(At the age of 15 days)
- Mother-to-infant bonding scale measured on day 29(After the newborn reaches 28 days of age)
- Breastfeeding self-efficacy scale (short form) measured on day 29(After the newborn reaches 28 days of age)
研究者
Aarti Kumar
Community Empowerment Lab