Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants
Brief Summary: This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (ciKMC) for low birth weight babies on post enrolment neonatal mortality and mortality post enrolment upto 6 months of age. This large individually randomized controlled trial will enroll 10500 low birth weight babies. The secondary objectives are examining the impact of the intervention on exclusive breast feeding and growth at 1 and 3 months, infections and hospitalizations in the neonatal period and from 1 to 5 months of age, recognition of illnesses and early care seeking from appropriate sources, motor and mental development in a subsample.

Newborns weighing \>=1500 to \<=2250gm are being enrolled into the study within 3 days of birth. Eligible babies are randomized to intervention or control arms. Mothers in the intervention arm are supported for KMC and breastfeeding by study ANM (Auxiliary Nurse Midwife) and study ASHA (Accredited Social Health Activist) like workers . Routine home visits are conducted in both intervention and control arms by government workers according to the existing government program.

Survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months.

The data safety and monitoring committee (DSMC) conducted two interim analyses, first in September 2017 when about half of the infants had been enrolled, and second in June 2018, when almost three quarters of the enrolled babies had been followed till 28 days of age. Following the second interim analysis, the DSMC concluded that a sufficient number of infants would be enrolled by the end to September 2018 to clearly answer the study question concerning the impact of ciKMC on both neonatal and early infant mortality. The DSMC recommended that data collection be completed by the end of October 2018.


Options:
A: Arm Label: Intervention KMC; Type: EXPERIMENTAL; Interventions: Behavioral: KMC, Other: Essential newborn care | Arm Label: Control; Type: OTHER; Interventions: Other: Essential newborn care | Intervention Type: BEHAVIORAL; Name: KMC; Assigned to Arm(s): Intervention KMC | Intervention Type: OTHER; Name: Essential newborn care; Assigned to Arm(s): Control, Intervention KMC
B: Arm Label: Assignment to FORNET; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: FORNET | Arm Label: Assignment to CBT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: CBT | Arm Label: Waiting List Control Group (camp); Type: OTHER; Interventions: Other: Waiting List Control Group (camp) | Arm Label: Waiting List Control Group (no camp); Type: OTHER; Interventions: Other: Waiting List Control Group (no camp) | Intervention Type: BEHAVIORAL; Name: FORNET; Assigned to Arm(s): Assignment to FORNET | Intervention Type: BEHAVIORAL; Name: CBT; Assigned to Arm(s): Assignment to CBT | Intervention Type: OTHER; Name: Waiting List Control Group (camp); Assigned to Arm(s): Waiting List Control Group (camp) | Intervention Type: OTHER; Name: Waiting List Control Group (no camp); Assigned to Arm(s): Waiting List Control Group (no camp)
C: Arm Label: Step-by-Step; Type: EXPERIMENTAL; Interventions: Behavioral: Step-by-Step | Arm Label: Enhanced care as usual; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced care as usual | Intervention Type: BEHAVIORAL; Name: Step-by-Step; Assigned to Arm(s): Step-by-Step | Intervention Type: BEHAVIORAL; Name: Enhanced care as usual; Assigned to Arm(s): Enhanced care as usual
D: Arm Label: Intervention Kangaroo Mother Care; Type: EXPERIMENTAL; Interventions: Behavioral: Kangaroo Mother Care | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Kangaroo Mother Care; Assigned to Arm(s): Intervention Kangaroo Mother Care

Answer: D