Maternal Role in Oral Feed Establishment in Preterm Neonates

Fatima Memorial Hospital

Status: Enrolling

Conditions: Swallowing Disorder; Tube Feeding; Maternal Care Patterns; Preterm Birth

Treatments: Other: perioral sensory motor stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05484726

FMH-07-2021-IRB-929-M

Details and patient eligibility

About

Hypothesis

Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will

1. Start taking oral feed at the same time as compared to control group
2. Take the same amount of milk at the commencement of oral feeding
3. Take milk with equal efficiency
4. Not face more adverse effects

Full description

Aim To determine the maternal role in sensory-motor stimulation for oral feed establishment in preterm neonates Objective

1. Determine the effect of sensory-motor stimulation offered by the mother on the onset of oral feeding

2. Efficiency of mother-mediated stimulation techniques on oral feeding as compared to trained nurses

3. Study maternal role in the establishment of oral feed Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will

4. Start taking oral feed at the same time frame as compared to the control group 2. Take the very same amount of milk at the commencement of oral feeding 3. Take milk with equal efficiency 4. There is no extra burden of adverse effects

Data Collection All on going and related trials for this intervention shall be registered in the ClinicalTrials.gov. Study shall be conducted after ethical approval from IRB. All participants shall be enrolled after written informed consent from mothers after approval from attending neonatologist (annexure 2). All relevant maternal and neonatal data shall be collected on a specially designed proforma (annexure 3) with following details

1. Part 1: Maternal demographic and clinical data (age, parity, educational qualification, residence, previous preterm baby, job status, diabetes, hypertensive disorders, chronic ailment, multifetal gestation

2. Part 2: Neonatal demographic data (gender, gestation age, birth weight, growth centiles, diagnosis, APGAR score, noninvasive (NIV) and invasive ventilation with duration, caffeine, days taken for establishment of gavage feeding, age, and weight at commencement of intervention, any other complication during study)

3. Part 3: Neonatal feeding physiological measurements (SpO2, respiratory rate, heart rate before and after feeding, daily weight gain, type of milk offered)

4. Part 4: Oral feeding skill (OFS) assessment adapted from the model presented by Lau and Smith (p). All parameters shall be recorded twice a day for D1, D2, and D3 separately. It includes

   • Total volume prescribed (ml)

   • Total volume has taken during feeding (ml)

   • Volume has taken during the first 5 min of feeding (ml)

   • Duration of oral feeding (min)

   • Overall transfer (OT %) volume taken/total volume prescribed

   • Proficiency(PRO%) volume taken during the first 5 min/total volume prescribed

   • Rate of transfer (RT) ml/min

   • SSB (Suck Swallow Breaths) coordination

   • Adverse events (cough, fatigue)

   • According to this oral feeding ability can be classified into four levels depending upon the level of maturity in ascending order as follows:

     • Level 1: PRO < 30% and RT < 1.5 ml/min
     • Level 2: PRO < 30% and RT ≥ 1.5 ml/min
     • Level 3: PRO ≥ 30% and RT < 1.5 ml/min
     • Level 4: PRO ≥ 30% and RT ≥ 1.5 ml/min

Enrollment: 46 estimated patients

Sex: All

Ages: 30 to 34 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All preterm of gestation age 28 to 34weeks
• Haemodynamically stable
• Established full Gavage feed
• No respiratory distress
• No need for respiratory support except LFNC
• Do not receive any kind of analgesics

Exclusion criteria

• Syndromic babies /genetic disorders
• Haemodynamically unstable babies including IVH (grade III & IV), hemodynamically significant PDA, NEC(any stage)
• Major malformations
• Cleft lip and palate
• Anemia requiring blood transfusion

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Intervention group (Group 1)

Experimental group

Description:

* Maternal involvement shall be in three stages for the intervention group as * Observer status * Performing under supervision * Independent * Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes) Intervention group (Group I): by mothers 1. T1: Nurses performing all steps while mother observer status 2. T2: Nurses perform all steps in front of the mother and a pacifier will be offered by the mother 3. D1: Mother performs all steps and oral milk shall be offered by the nurse while the mother observes. 4. D2: Mother performing all steps and offering oral milk while the nurse is supervising 5. D3: Mother performing all steps independently

Treatment:

Other: perioral sensory motor stimulation

Control group (Group 2)

Sham Comparator group

Description:

All steps will be the same as the intervention group and shall be performed by staff nurses

Treatment:

Other: perioral sensory motor stimulation