Effect of Mother newborn Dyad NICU care as compared to conventional NICU in preterm or very low birth weight neonates requiring NICU care in a Level 3 NICU setting on head growth velocity trajectory- randomized control trial

EFFECT OF MOTHER NEWBORN DYAD LEVEL 3 NICU CARE ON HEAD SIZE GROWTH TRAJECTORY IN VERY LOW BIRTH WEIGHT INFANTS TILL TERM EQUIVALENT AGE COMPARED WITH CONVENTIONAL LEVEL 3 NICU CARE- A RANDOMIZED CONTROLLED TRIAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049648

Enrollment

100

Registered

2023-02-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Mother newborn dyad care facility: NICU care will be provided in the same manner like conventional NICU but accommodation will be given to mothers near their baby. Mother will be shifte

Eligibility

Inclusion criteria

Inclusion criteria: All inborn neonates,less than 32 weeks gestation or less than 1500 grams birth weight requirirng NICU admission at birth.

Exclusion criteria

Exclusion criteria: 1. Babies known to be requiring surgical intervention at the time of NICU admission. 2. Babies with major congenital malformations. 3. Babies whose mother is sick and unlikely to be providing newborn care in first 72 hours after birth in NICU. 4. Non availability of NICU bed.

Design outcomes

Primary

Measure	Time frame
Head circumference in cmTimepoint: 39Â± 2 weeks of post mensural age in	—

Secondary

Measure	Time frame
1)Neonatal mortality: Proportion of babies expired till discharge. 2)Neonatal morbidities: Proportion of babies developing sepsis, Number of sepsis episodes in babies; Proportion of babies developing Stage 2b or higher NEC; Proportion of babies developing BPD; Proportion of babies having grade 2/ 3 IVH; Proportion of babies developing Retinopathy of prematurity. 3)Duration of hospital stay in terms of calendar days. 4)Duration of mechanical ventilation in terms of calendar days. 5)Time required to regain birth weight in terms of calendar days Time to achieve full feeds in terms of Day of life. Timepoint: Till discharge	—

Measure

Time frame

1)Neonatal mortality: Proportion of babies expired till discharge. 2)Neonatal morbidities: Proportion of babies developing sepsis, Number of sepsis episodes in babies; Proportion of babies developing Stage 2b or higher NEC; Proportion of babies developing BPD; Proportion of babies having grade 2/ 3 IVH; Proportion of babies developing Retinopathy of prematurity. 3)Duration of hospital stay in terms of calendar days. 4)Duration of mechanical ventilation in terms of calendar days. 5)Time required to regain birth weight in terms of calendar days Time to achieve full feeds in terms of Day of life. Timepoint: Till discharge

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Countries

India

Contacts

Public ContactDevansh Sharma

AIIMS Jodhpur

thanigaipaeds@yahoo.com9176078520

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026